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Acta Ophthalmologica Feb 2022Osteogenesis imperfecta (OI) is a rare inherited heterogeneous connective tissue disorder characterized by bone fragility, low bone mineral density, skeletal deformity...
PURPOSE
Osteogenesis imperfecta (OI) is a rare inherited heterogeneous connective tissue disorder characterized by bone fragility, low bone mineral density, skeletal deformity and blue sclera. The dominantly inherited forms of OI are predominantly caused by mutations in either the COL1A1 or COL1A2 gene. Collagen type I is one of the major structural proteins of the eyes and therefore is the eye theoretically prone to alterations in OI. The aim of this systematic review was to provide an overview of the known ocular problems reported in OI.
METHODS
A literature search (in PubMed, Embase and Scopus), which included articles from inception to August 2020, was performed in accordance with the PRISMA guidelines.
RESULTS
The results of this current review show that almost every component of the eye could be affected in OI. Decreased thickness of the cornea and sclera is an important factor causing eye problems in patients with OI such as blue sclera. Findings that stand out are ruptures, lacerations and other eye problems that occur after minor trauma, as well as complications from standard surgical procedures.
DISCUSSION
Alterations in collagen type I affect multiple structural components of the eye. It is recommended that OI patients wear protective glasses against accidental eye trauma. Furthermore, when surgery is required, it should be approached with caution. The prevalence of eye problems in different types of OI is still unknown. Additional research is required to obtain a better understanding of the ocular defects that may occur in OI patients and the underlying pathology.
Topics: Blindness; Collagen Type I; Eye Diseases; Humans; Mutation; Osteogenesis Imperfecta; Phenotype; Risk Factors
PubMed: 34009739
DOI: 10.1111/aos.14882 -
Asia-Pacific Journal of Ophthalmology... Jan 2021We performed a systematic review on 3 major types of scleral-fixated intraocular lens (SFIOL) implantations and conducted subgroup analyses on pediatric population and...
PURPOSE
We performed a systematic review on 3 major types of scleral-fixated intraocular lens (SFIOL) implantations and conducted subgroup analyses on pediatric population and subjects with Marfan syndrome.
DESIGN
Systematic review.
METHODS
We performed a search in PubMed, Ovid MEDLINE, and Embase for English language articles with keywords "(sutured intraocular lens) OR (SFIOL) OR (sutureless intraocular lens) OR (glued intraocular lens) OR (intrascleral intraocular lens) OR (SFIOL)" through October 16, 2019. Articles reporting individual outcomes after SFIOL were included in this systematic review. Recorded outcome measures included intraoperative and postoperative complications, endothelial cell changes, and intraocular lens-related outcomes.
RESULTS
Our search yielded 217 papers. After removing duplicated and irrelevant reports, we included 57 articles involving 2624 eyes. The mean age at operation was 51.47 ± 25.62 years. Sutured SFIOL was most commonly reported in all subjects with Marfan syndrome and 92.87% of pediatric patients. The pooled intraoperative complication rate was 6.65%. Minor anterior chamber hemorrhage was the most common intraoperative (1.92%) and postoperative complication (13.93%). Optic capture was the top intraocular lens (IOL)-related complication (4.47%). The overall mean endothelial cell loss was 8.95% at 16.77 ± 11.04 months. Overall 11.99% of SFIOLs were decentred with a mean distance of 0.49 ± 0.40 mm and a mean degree of tilt by 4.11 ± 3.03°.
CONCLUSIONS
Glued SFIOL had the fewest IOL-related complications and the lowest endothelial cell loss. Sutured SFIOL carried the highest IOL-related complications, whereas sutureless, glueless SFIOL was associated with the greatest endothelial cell loss.
Topics: Humans; Lens Implantation, Intraocular; Lenses, Intraocular; Postoperative Complications; Retrospective Studies; Sclera; Suture Techniques; Visual Acuity
PubMed: 33481393
DOI: 10.1097/APO.0000000000000369 -
The Cochrane Database of Systematic... Aug 2020Primary congenital glaucoma (PCG) is an optic neuropathy with high intraocular pressure (IOP) that manifests within the first few years of a child's life and is not... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Primary congenital glaucoma (PCG) is an optic neuropathy with high intraocular pressure (IOP) that manifests within the first few years of a child's life and is not associated with other systemic or ocular abnormalities. PCG results in considerable morbidity even in high-income countries.
OBJECTIVES
To compare the effectiveness and safety of different surgical techniques for PCG.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (2020, Issue 4); Ovid MEDLINE; Embase.com; PubMed; metaRegister of Controlled Trials (mRCT) (last searched 23 June 2014); ClinicalTrials.gov; and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). We did not use any date or language restrictions in the electronic search. We last searched the electronic databases on 27 April 2020.
SELECTION CRITERIA
We included randomized controlled trials (RCTs) and quasi-RCTs comparing different surgical interventions in children under five years of age with PCG.
DATA COLLECTION AND ANALYSIS
We used standard Cochrane methodology.
MAIN RESULTS
We included 16 trials (13 RCTs and three quasi-RCTs) with 587 eyes in 446 children. Eleven (69%) trials were conducted in Egypt and the Middle East, three in India, and two in the USA. All included trials involved children younger than five years of age, with follow-up ranging from six to 80 months. The interventions compared varied across trials. Three trials (on 68 children) compared combined trabeculotomy and trabeculectomy (CTT) with trabeculotomy. Meta-analysis of these trials suggests there may be little to no evidence of a difference between groups in mean IOP (mean difference (MD) 0.27 mmHg, 95% confidence interval (CI) -0.74 to 1.29; 88 eyes; 2 studies) and surgical success (risk ratio (RR) 1.01, 95% CI 0.90 to 1.14; 102 eyes; 3 studies) at one year postoperatively. We assessed the certainty of evidence as very low for these outcomes, downgrading for risk of bias (-1) and imprecision (-2). Hyphema was the most common adverse outcome in both groups (no meta-analysis due to considerable heterogeneity; I = 83%). Two trials (on 39 children) compared viscotrabeculotomy to conventional trabeculotomy. Meta-analysis of 42 eyes suggests there is no evidence of between groups difference in mean IOP (MD -1.64, 95% CI -5.94 to 2.66) and surgical success (RR 1.11, 95% CI 0.70 to 1.78) at six months postoperatively. We assessed the certainty of evidence as very low, downgrading for risk of bias and imprecision due to small sample size. Hyphema was the most common adverse outcome (38% in viscotrabeculotomy and 28% in conventional trabeculotomy), with no evidence of difference difference (RR 1.33, 95% CI 0.63 to 2.83). Two trials (on 95 children) compared microcatheter-assisted 360-degree circumferential trabeculotomy to conventional trabeculotomy. Meta-analysis of two trials suggests that mean IOP may be lower in the microcatheter group at six months (MD -2.44, 95% CI -3.69 to -1.19; 100 eyes) and at 12 months (MD -1.77, 95% CI -2.92 to -0.63; 99 eyes); and surgical success was more likely to be achieved in the microcatheter group compared to the conventional trabeculotomy group (RR 1.59, 95% CI 1.14 to 2.21; 60 eyes; 1 trial at 6 months; RR 1.54, 95% CI 1.20 to 1.97; 99 eyes; 2 trials at 12 months). We assessed the certainty of evidence for these outcomes as moderate due to small sample size. Hyphema was the most common adverse outcome (40% in the microcatheter group and 17% in the conventional trabeculotomy group), with greater likelihood of occurring in the microcatheter group (RR 2.25, 95% CI 1.25 to 4.04); the evidence was of moderate certainty due to small sample size (-1). Of the nine remaining trials, no two trials compared the same two surgical interventions: one trial compared CTT versus CTT with sclerectomy; three trials compared various suturing techniques and adjuvant use including mitomycin C, collagen implant in CTT; one trial compared CTT versus Ahmed valve implant in previously failed surgeries; one trial compared CTT with trabeculectomy; one trial compared trabeculotomy to goniotomy; and two trials compared different types of goniotomy. No trials reported quality of life or economic data. Many of the included trials had limitations in study design, implementation, and reporting, therefore the reliability and applicability of the evidence remains unclear.
AUTHORS' CONCLUSIONS
The evidence suggests that there may be little to no evidence of difference between CTT and routine conventional trabeculotomy, or between viscotrabeculotomy and routine conventional trabeculotomy. A 360-degree circumferential trabeculotomy may show greater surgical success than conventional trabeculotomy. Considering the rarity of the disease, future research would benefit from a multicenter, possibly international trial, involving parents of children with PCG and with a follow-up of at least one year.
Topics: Child, Preschool; Glaucoma; Glaucoma Drainage Implants; Humans; Hyphema; Infant; Infant, Newborn; Intraocular Pressure; Mitomycin; Postoperative Complications; Randomized Controlled Trials as Topic; Sclera; Trabecular Meshwork; Trabeculectomy; Treatment Outcome
PubMed: 32816311
DOI: 10.1002/14651858.CD008213.pub3 -
PloS One 2020High myopia is a sight-threatening disease that causes axial length elongation and severe complications. Data on the benefits of posterior scleral reinforcement surgery... (Meta-Analysis)
Meta-Analysis
BACKGROUND
High myopia is a sight-threatening disease that causes axial length elongation and severe complications. Data on the benefits of posterior scleral reinforcement surgery in myopia control have been conflicting. The purpose of this study was to explore the treatment effect and complications of posterior scleral reinforcement in the treatment of myopia.
METHODS
Articles were retrieved for relevant studies from inception to July 24, 2019, by PubMed, EMBASE, and Ovid. Analyses were conducted to compare the treatment effects of controlling spherical equivalent refraction and axial length elongation. The weighted mean difference and Hedges' adjusted g were used to evaluate the treatment effects, with a random-effects model. Heterogeneity was quantified using I2 statistic and explored by subgroup analysis. Publication bias was addressed by funnel plots and Egger's test.
RESULTS
A total of 11 articles were included in this meta-analysis. On estimating the treatment effect, the mean differences of myopia progression and axial length changes between surgery and control groups were 0.41 diopters per year (95% CI 0.21 to 0.61; P < .001) and -0.17 mm per year (95% CI -0.22 to -0.11; P < .001). Subgroup analysis showed significant treatment effects of the single wide strip operation. Single-arm meta-analysis showed less annual axial elongation in children subgroup. These results were robust by sensitivity analysis. The incidence of some major complications in the operation group were significantly greater (5.8% vs 2.7% for myopic degeneration; 2.3% vs 1.6% for macular hemorrhage; 0.8% vs 0 for retinal detachment).
CONCLUSION
Posterior scleral reinforcement may be an effective surgery on controlling myopia progression by slowing both refraction and axial length change. However, frequent surgical complications should be considered. Further well-designed studies are needed to determine the long-term safety and efficacy.
Topics: Axial Length, Eye; Disease Progression; Female; Humans; Male; Myopia; Myopia, Degenerative; Ophthalmologic Surgical Procedures; Refraction, Ocular; Retinal Detachment; Sclera; Visual Acuity
PubMed: 32453804
DOI: 10.1371/journal.pone.0233564 -
Ophthalmic Research 2021Scleral and iris fixation of intraocular lenses (IOL) are useful in the treatment of surgical or traumatic aphakia, luxation, and subluxation of IOL if the patient does...
Scleral and iris fixation of intraocular lenses (IOL) are useful in the treatment of surgical or traumatic aphakia, luxation, and subluxation of IOL if the patient does not present appropriate capsular support. However, there is no consensus in the literature about which of these 2 methods is safer and better. The authors performed a literature review searching the main postoperative outcomes obtained with the use of each surgical method. Scleral and iris fixation of IOL are efficient in correction of the patients' visual acuity, even though each technique presents distinct complications which depend especially on the experience of the surgeon with the performed surgical method. It is important to understand that individuals submitted to scleral or iris fixation present previous preoperative complications in their eyes. Besides, both procedures are very complex, involving intense manipulation of the eye globe. The success rate of these surgical techniques is highly variable and has a close relation to the preoperative conditions of the patient's eye and the improvement of the surgeon's learning curve.
Topics: Humans; Iris; Lens Diseases; Lens Implantation, Intraocular; Lenses, Intraocular; Sclera; Suture Techniques; Visual Acuity
PubMed: 32163944
DOI: 10.1159/000507120 -
Ophthalmic Research 2020Myopia, especially high myopia, would cause damage in the choroid, retina and sclera, thereby leading to vision loss. Although refractive error correction can help... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Myopia, especially high myopia, would cause damage in the choroid, retina and sclera, thereby leading to vision loss. Although refractive error correction can help improve visual acuity, the pathology of myopia, a global issue, remains unclear and myopia progression, as well as concomitant fundus progression, remains uncontrolled. Under such circumstances, prevention of myopia is of great significance and thus should be prioritized.
OBJECTIVE
To explore whether outdoor time has positive significance for myopia prevention.
SEARCH METHODS
Databases of Pubmed, Science Direct, the Cochrane Library, the Chinese National Knowledge Infrastructure and the Wanfang Database were searched. The following terms or their combinations were used: myopia, prevention, control, random, randomized, randomization, intervention, outdoor. The full search strategy was shown in the Appendix below. The databases were last searched on -October 24, 2018.
SELECTION CRITERIA
Randomized controlled trials (RCTs) that participants accepted outdoor activity as an intervention measure for myopia prevention were included.
DATA COLLECTION AND ANALYSIS
Two review authors independently extracted data and assessed the risk of bias for included studies. A fixed-effects model was applied, given that the heterogeneity among included studies was small.
MAIN RESULTS
Five RCTs with 3,014 subjects were included. Subjects' age ranged from 6 to 12 years, and the follow-up duration ranged from 9 to 36 months. Spherical equivalent error (SER) of the outdoor group was larger than that of the control group, and the pooled mean difference (MD) was 0.15 (95% CI 0.06-0.23) diopter (D). The change in SER of the outdoor group was smaller than that of the control group, with a pooled MD of 0.17 (95% CI 0.16-0.18) D. New myopia cases in the outdoor group were fewer than that of the control group, and the pooled risk ratio was 0.76 (95% CI 0.67-0.87). The change in axial length of the outdoor group was smaller than that of the control group, and the pooled MD was -0.03 (95% CI -0.03 to -0.03) mm. For all analyzed outcomes, there was no heterogeneity across included studies (I2 = 0%) and there was no publication bias either.
CONCLUSION
Outdoor time helps slow down the change of axial length and reduce the risk of myopia.
Topics: Humans; Myopia; Randomized Controlled Trials as Topic; Seasons; Time Factors; Visual Acuity
PubMed: 31430758
DOI: 10.1159/000501937 -
BMC Ophthalmology Nov 2017Anti-fibrotic, anti-VEGF (vascular endothelial growth factor) medications, or radiotherapy, as adjuvant for pterygium surgical procedure, has been suggested for reducing... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Anti-fibrotic, anti-VEGF (vascular endothelial growth factor) medications, or radiotherapy, as adjuvant for pterygium surgical procedure, has been suggested for reducing recurrence, but difficulties may be experienced in deciding which treatment to use. The purpose of this study was to compare the efficacies of these different adjuvants for preventing recurrence following pterygium surgery.
METHODS
We conducted a systematic review to identify randomized controlled trials of patients with primary or recurrent pterygium who received anti-fibrotic, anti-VEGF medication, or radiotherapy as adjuvants in combination with surgical procedure. The surgical procedure contained bare sclera technique or petrygium excision combination with tissue grafting. The primary outcome of this study was recurrence. Direct-comparison and Bayesian network meta-analyses were performed to assess direct and indirect evidence of efficacy.
RESULTS
We obtained data from 34 randomized controlled trials, representing a total of 2483 patients. Adjuvants included bevacizumab, 5-FU (5-fluorouracil), MMC (mitomycin C), and β-RT (beta-radiotherapy). Compared with placebo, we found distinguishable improvement in recurrence with bevacizumab (odds ratio [OR] 0.38, 95% confidence interval [CI] 0.18-0.80), MMC (0.12, 95% CI 0.06-0.21), and β-RT (0.17, 95% CI 0.04-0.69), but not with 5-FU (0.41, 95% CI 0.12-1.39). MMC significantly reduced recurrence when compared to bevacizumab (0.31, 95% CI 0.13-0.77) and 5-FU (0.28, 95% CI 0.08-0.99). The probability of having the most recurrences after excision was lowest for MMC, followed by bevacizumab and β-RT. Similar results were found in subgroup analyses, including for primary pterygium, and the patients receiving bare sclera technique or conjunctival autograft.
CONCLUSIONS
Adjuvants such as MMC, bevacizumab, and β-RT could effectively prevent recurrence following pterygium excision. However, their efficacy and acceptability require further clarification in future randomized controlled trials.
Topics: Alkylating Agents; Angiogenesis Inhibitors; Antifibrinolytic Agents; Chemotherapy, Adjuvant; Humans; Ophthalmologic Surgical Procedures; Primary Prevention; Pterygium; Radiotherapy, Adjuvant; Randomized Controlled Trials as Topic; Recurrence; Secondary Prevention; Vascular Endothelial Growth Factor A
PubMed: 29178848
DOI: 10.1186/s12886-017-0601-5 -
The Cochrane Database of Systematic... Dec 2016Pterygium, a growth of the conjunctiva over the cornea, is a progressive disease leading in advanced stages to visual impairment, restriction of ocular motility, chronic... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Pterygium, a growth of the conjunctiva over the cornea, is a progressive disease leading in advanced stages to visual impairment, restriction of ocular motility, chronic inflammation and cosmetic concerns. Surgical removal is the treatment of choice, but recurrence can be a problem. Currently the best surgical option in terms of recurrence is conjunctival autograft. To date the most common surgical methods of attaching conjunctival autografts to the sclera are through suturing or fibrin glue. Each method presents its own advantages and disadvantages. Sutures require considerable skill from the surgeon and can be associated with a prolonged operation time, postoperative discomfort and suture-related complications, whereas fibrin glue may give a decreased operation time, improve postoperative comfort and avoid suture-related problems.
OBJECTIVES
To assess the effectiveness of fibrin glue compared to sutures in conjunctival autografting for the surgical treatment of pterygium.
SEARCH METHODS
We searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register) (2016, Issue 9), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to October 2016), Embase (January 1980 to October 2016), the ISRCTN registry (www.isrctn.com/editAdvancedSearch), ClinicalTrials.gov (www.clinicaltrials.gov), and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 14 October 2016.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) in any setting where fibrin glue was compared with sutures to treat people with pterygium.
DATA COLLECTION AND ANALYSIS
Two review authors independently screened the search results, assessed trial quality, and extracted data using standard methodological procedures expected by Cochrane. Our primary outcome was recurrence of pterygium defined as any re-growth of tissue from the area of excision across the limbus onto the cornea. The secondary outcomes were surgical time and complication rate. We graded the certainty of the evidence using GRADE.
MAIN RESULTS
We included 14 RCTs conducted in Brazil, China, Egypt, India, Malaysia, New Zealand, Philippines, Saudi Arabia, Sweden and Turkey. The trials were published between 2004 and 2016, and were assessed as a mixture of unclear and low risk of bias with three studies at high risk of attrition bias. Only adults were enrolled in these studies.Using fibrin glue for the conjunctival autograft may result in less recurrence of pterygium compared with using sutures (risk ratio (RR) 0.47, 95% CI 0.27 to 0.82, 762 eyes, 12 RCTs; low-certainty evidence). If pterygium recurs after approximately 10 in every 100 surgeries with sutures, then using fibrin glue may result in approximately 5 fewer cases of recurrence in every 100 surgeries (95% CI 2 fewer to 7 fewer cases). Using fibrin glue may lead to more complications compared with sutures (RR 1.92; 95% CI 1.22 to 3.02, 11 RCTs, 673 eyes, low-certainty evidence). The most common complications reported were: graft dehiscence, graft retraction and granuloma. On average using fibrin glue may mean that surgery is quicker compared with suturing (mean difference (MD) -17.01 minutes 95% CI -20.56 to -13.46), 9 RCTs, 614 eyes, low-certainty evidence).
AUTHORS' CONCLUSIONS
The meta-analyses, conducted on people with pterygium in a hospital or outpatient setting, show fibrin glue may result in less recurrence and may take less time than sutures for fixing the conjunctival graft in place during pterygium surgery. There was low-certainty evidence to suggest a higher proportion of complications in the fibrin glue group.
Topics: Autografts; Conjunctiva; Fibrin Tissue Adhesive; Humans; Pterygium; Randomized Controlled Trials as Topic; Recurrence; Secondary Prevention; Sutures; Tissue Adhesives; Transplantation, Autologous
PubMed: 27911983
DOI: 10.1002/14651858.CD011308.pub2 -
The Cochrane Database of Systematic... Feb 2016A pterygium is a fleshy, wing-shaped growth from the conjunctiva, crossing over the limbus onto the cornea. Prevalence ranges widely around the world. Evidence suggests... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
A pterygium is a fleshy, wing-shaped growth from the conjunctiva, crossing over the limbus onto the cornea. Prevalence ranges widely around the world. Evidence suggests that ultraviolet light is a major contributor in the formation of pterygia. Pterygia impair vision, limit eye movements, and can cause eye irritation, foreign body sensation, and dryness. In some susceptible patients, the pterygium can grow over the entire corneal surface, blocking the visual axis.Surgery is the only effective treatment for pterygium, though recurrences are common. With simple excision techniques (that is, excising the pterygium and leaving bare sclera), the risk of recurrence has been reported to be upwards of 80%. Pterygium excision combined with a tissue graft has a lower risk of recurrence. In conjunctival autograft surgery, conjunctival tissue from another part of the person's eye along with limbal tissue is resected in one piece and used to cover the area from which the pterygium was excised. Another type of tissue graft surgery for pterygium is amniotic membrane graft, whereby a piece of donor amniotic membrane is fixed to the remaining limbus and bare sclera area after the pterygium has been excised.
OBJECTIVES
The objective of this review was to assess the safety and effectiveness of conjunctival autograft (with or without adjunctive therapy) compared with amniotic membrane graft (with or without adjunctive therapy) for pterygium. We also planned to determine whether use of MMC yielded better surgical results and to assess the direct and indirect comparative costs of these procedures.
SEARCH METHODS
We searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register) (Issue 10, 2015), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to November 2015), EMBASE (January 1980 to November 2015), PubMed (1948 to November 2015), Latin American and Caribbean Health Sciences Literature Database (LILACS) (1982 to November 2015), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com) (last searched 21 November 2014), ClinicalTrials.gov (www.clinicaltrials.gov) and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic search for trials. We last searched the electronic databases on 23 November 2015.
SELECTION CRITERIA
We included in this review randomized controlled trials that had compared conjunctival autograft surgery (with or without adjunctive therapy) with amniotic membrane graft surgery (with or without adjunctive therapy) in people with primary or recurrent pterygium.
DATA COLLECTION AND ANALYSIS
Two review authors independently screened search results and assessed full-text reports from among the potentially eligible trials. Two review authors independently extracted data from the included trials and assessed the trial characteristics and risk of bias. The primary outcome was the risk of recurrence of pterygium at 3 months and 6 months after surgery. We combined results from individual studies in meta-analyses using random-effects models. Risk of recurrence of pterygium was reported using risk ratios to compare conjunctival autograft with amniotic membrane transplant.
MAIN RESULTS
We identified 20 studies that had analyzed a total of 1947 eyes of 1866 participants (individual studies ranged from 8 to 346 participants who were randomized). The studies were conducted in eight different countries: one in Brazil, three in China, three in Cuba, one in Egypt, two in Iran, two in Thailand, seven in Turkey, and one in Venezuela. Overall risk of bias was unclear, as many studies did not provide information on randomization methods or masking to prevent performance and detection bias.The risk ratio for recurrence of pterygium using conjunctival autograft versus amniotic membrane transplant was 0.87 (95% confidence interval (CI) 0.43 to 1.77) and 0.53 (95% CI 0.33 to 0.85) at 3 months and 6 months, respectively. These estimates include participants with primary and recurrent pterygia. We performed a subgroup analysis to compare participants with primary pterygia with participants with recurrent pterygia. For participants with primary pterygia, the risk ratio was 0.92 (95% CI 0.37 to 2.30) and 0.58 (95% CI 0.27 to 1.27) at 3 months and 6 months, respectively. We were only able to estimate the recurrence of pterygia at 6 months for participants with recurrent pterygia, and the risk ratio comparing conjunctival autograft with amniotic membrane transplant was 0.45 (95% CI 0.21 to 0.99). One included study was a doctoral thesis and did not use allocation concealment. When this study was excluded in a sensitivity analysis, the risk ratio for pterygium recurrence at 6 months' follow-up was 0.43 (95% CI 0.30 to 0.62) for participants with primary and recurrent pterygium. One of the secondary outcomes, the proportion of participants with clinical improvement, was analyzed in only one study. This study reported clinical outcome as the risk of non-recurrence, which was seen in 93.8% of participants in the conjunctival limbal autograft group and 93.3% in the amniotic membrane transplant group at 3 months after surgery.We did not analyze data on the need for repeat surgery, vision-related quality of life, and direct and indirect costs of surgery due to an insufficient number of studies reporting these outcomes.Thirteen studies reported adverse events associated with conjunctival autograft surgery and amniotic membrane transplant surgery. Adverse events that occurred in more than one study were granuloma and pyogenic granuloma and increased intraocular pressure. None of the included studies reported that participants had developed induced astigmatism.
AUTHORS' CONCLUSIONS
In association with pterygium excision, conjunctival autograft is associated with a lower risk of recurrence at six months' after surgery than amniotic membrane transplant. Participants with recurrent pterygia in particular have a lower risk of recurrence when they receive conjunctival autograft surgery compared with amniotic membrane transplant. There are few studies comparing the two techniques with respect to visual acuity outcomes, and we identified no studies that reported on vision-related quality of life or direct or indirect costs. Comparison of these two procedures in such outcome measures bears further investigation. There were an insufficient number of studies that used adjunctive mitomycin C to estimate the effects on pterygium recurrence following conjunctival autograft or amniotic membrane transplant.
Topics: Amnion; Autografts; Conjunctiva; Humans; Pterygium; Randomized Controlled Trials as Topic; Recurrence; Time Factors
PubMed: 26867004
DOI: 10.1002/14651858.CD011349.pub2 -
The Cochrane Database of Systematic... Nov 2015Glaucoma is one of the leading largely preventable causes of blindness in the world. It usually is addressed first medically with topical intraocular pressure-lowering... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Glaucoma is one of the leading largely preventable causes of blindness in the world. It usually is addressed first medically with topical intraocular pressure-lowering drops or by laser trabeculoplasty. In cases where such treatment fails, glaucoma-filtering surgery is considered, most commonly trabeculectomy surgery with variations in technique, for example, the type of conjunctival flap (fornix- or limbal-based). In a fornix-based flap, the surgical wound is performed at the corneal limbus; while in a limbal-based flap, the incision is further away. Many studies in the literature compare fornix- and limbal-based trabeculectomy with respect to outcomes and complications.
OBJECTIVES
To assess the comparative effectiveness of fornix- versus limbal-based conjunctival flaps in trabeculectomy for adult glaucoma, with a specific focus on intraocular pressure (IOP) control and complications (adverse effects).
SEARCH METHODS
We searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register) (2015, Issue 9), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to October 2015), EMBASE (January 1980 to October 2015), Latin American and Caribbean Health Sciences Literature Database (LILACS) (January 1982 to October 2015), the ISRCTN registry (www.isrctn.com/editAdvancedSearch), ClinicalTrials.gov (www.clinicaltrials.gov) and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 23 October 2015.We reviewed the bibliographic references of identified randomised controlled trials (RCTs) in order to find trials not identified by the electronic searches. We contacted researchers and practitioners active in the field of glaucoma to identify other published and unpublished trials.
SELECTION CRITERIA
We included RCTs comparing the benefits and complications of fornix- versus limbal-based trabeculectomy for glaucoma, irrespective of glaucoma type, publication status, and language. We excluded studies on children less than 18 years of age, since wound healing is different in this age group and the rate of bleb scarring postoperatively is high.
DATA COLLECTION AND ANALYSIS
Two review authors independently extracted data and assessed trial quality. We contacted study authors for additional information.The primary outcome was the proportion of failed trabeculectomies at 24 months. Failure was defined as the need for repeat surgery or uncontrolled IOP (more than 22 mmHg), despite additional topical/systemic medications. Needling and 5-fluorouracil (5-FU) injections were allowed only during the first six months postoperatively; additional needling or 5-FU injections were considered as failure. Mean post-operative IOP at 12 and 24 months also was recorded.
MAIN RESULTS
The review included six trials with a total of 361 participants. Two studies were conducted in America and one each in Germany, Greece, India, and Saudi Arabia. The participants of four trials had open-angle glaucoma; one study included participants with primary open-angle or primary closed-angle glaucoma, and one study did not specify the type of glaucoma. Three studies used a combined procedure (phacotrabeculectomy). Trabeculectomy with mitomycin C (MMC) was performed in four studies, and trabeculectomy with 5-fluorouracil (5-FU) was performed in only one study.None of the included trials reported trabeculectomy failure at 24 months. Only one trial reported the failure rate of trabeculectomy as a late complication. Failure was higher among participants randomised to the limbal-based surgery: 1/50 eyes failed trabeculectomy in the fornix group compared with 3/50 in the limbal group (risk ratio (RR) 0.33, 95% confidence interval (95% CI) 0.04 to 3.10); therefore we are very uncertain as to the relative effect of the two procedures on failure rate.Four studies including 252 participants provided measures of mean IOP at 12 months. In the fornix-based surgeries, mean IOP ranged from 12.5 to 15.5 mmHg and similar results were noted in limbal-based surgeries with mean IOP ranging from 11.7 to 15.1 mmHg without significant difference. Mean difference was 0.44 mmHg (95% CI -0.45 to 1.33) and 0.86 mmHg, (95% CI -0.52 to 2.24) at 12 and 24 months of follow-up, respectively. Neither of these pooled analyses showed a statistically significant difference in IOP between groups (moderate quality of evidence).One trial reported number of anti-glaucoma medications at 24 months of follow-up with no difference noted between surgical groups. However, three trials reported the mean number of anti-glaucoma medications at 12 months of follow-up without significant difference in the mean number of postoperative IOP-lowering medications between the two surgical techniques. Mean difference was 0.02, (95% CI -0.15 to 0.19) at 12 months of follow-up (high quality of evidence).Because of the small numbers of events and total participants, the risk of many reported adverse events were uncertain and those that were found to be statistically significant may have been due to chance.For risk of bias assessment: although all six trials were randomised selection bias was mostly unclear, with unclear random sequence generation in four of the six studies and unclear allocation concealment in five of the six studies. Attrition bias was encountered in only one trial which also suffered from reporting bias. All other trials had an unclear risk of reporting bias as there was no access to study protocols. All included trials were judged to have high risk of detection bias due to lack of masking of the outcomes. Trabeculectomy is quite a standard procedure and unlikely to induce bias due to surgeon 'performance', hence performance bias was not evaluated.
AUTHORS' CONCLUSIONS
The main result of this review was that there was uncertainty as to the difference between fornix- and limbal-based trabeculectomy surgeries due to the small number of events and confidence intervals that cross the null. This also applied to postoperative complications, but without any impact on long-term failure rate between the two surgical techniques.
Topics: Antihypertensive Agents; Fluorouracil; Glaucoma; Humans; Intraocular Pressure; Limbus Corneae; Mitomycin; Randomized Controlled Trials as Topic; Sclera; Surgical Flaps; Trabeculectomy; Treatment Failure
PubMed: 26599668
DOI: 10.1002/14651858.CD009380.pub2