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Ophthalmology Feb 2023The Laser in Glaucoma and Ocular Hypertension (LiGHT) Trial has shown selective laser trabeculoplasty (SLT) to be clinically and cost-effective as a primary treatment of... (Randomized Controlled Trial)
Randomized Controlled Trial
Laser in Glaucoma and Ocular Hypertension (LiGHT) Trial: Six-Year Results of Primary Selective Laser Trabeculoplasty versus Eye Drops for the Treatment of Glaucoma and Ocular Hypertension.
PURPOSE
The Laser in Glaucoma and Ocular Hypertension (LiGHT) Trial has shown selective laser trabeculoplasty (SLT) to be clinically and cost-effective as a primary treatment of open-angle glaucoma (OAG) and ocular hypertension (OHT) at 3 years. This article reports health-related quality of life (HRQoL) and clinical effectiveness of initial treatment with SLT compared with intraocular pressure (IOP)-lowering eye drops after 6 years of treatment.
DESIGN
Prospective, multicenter randomized controlled trial.
PARTICIPANTS
Treatment-naive eyes with OAG or OHT initially treated with SLT or IOP-lowering drops.
METHODS
Patients were allocated randomly to initial SLT or eye drops. After the initial 3 years of the trial, patients in the SLT arm were permitted a third SLT if necessary; patients in the drops arm were allowed SLT as a treatment switch or escalation. This study is registered at controlled-trials.com (identifier, ISRCTN32038223).
MAIN OUTCOME MEASURES
The primary outcome was HRQoL at 6 years; secondary outcomes were clinical effectiveness and adverse events.
RESULTS
Of the 692 patients completing 3 years in the LiGHT Trial, 633 patients (91.5%) entered the extension, and 524 patients completed 6 years in the trial (82.8% of those entering the extension phase). At 6 years, no significant differences were found for the EuroQol EQ-5D 5 Levels, Glaucoma Utility Index, and Glaucoma Quality of Life-15 (P > 0.05 for all). The SLT arm showed better Glaucoma Symptom Scale scores than the drops arm (83.6 ± 18.1 vs. 81.3 ± 17.3, respectively). Of eyes in the SLT arm, 69.8% remained at or less than the target IOP without the need for medical or surgical treatment. More eyes in the drops arm exhibited disease progression (26.8% vs. 19.6%, respectively; P = 0.006). Trabeculectomy was required in 32 eyes in the drops arm compared with 13 eyes in the SLT arm (P < 0.001); more cataract surgeries occurred in the drops arm (95 compared with 57 eyes; P = 0.03). No serious laser-related adverse events occurred.
CONCLUSIONS
Selective laser trabeculoplasty is a safe treatment for OAG and OHT, providing better long-term disease control than initial drop therapy, with reduced need for incisional glaucoma and cataract surgery over 6 years.
Topics: Humans; Trabeculectomy; Glaucoma, Open-Angle; Ophthalmic Solutions; Quality of Life; Prospective Studies; Glaucoma; Ocular Hypertension; Intraocular Pressure; Laser Therapy; Lasers; Treatment Outcome; Cataract
PubMed: 36122660
DOI: 10.1016/j.ophtha.2022.09.009 -
BMJ (Clinical Research Ed.) May 2021To determine whether primary trabeculectomy or primary medical treatment produces better outcomes in term of quality of life, clinical effectiveness, and safety in...
OBJECTIVE
To determine whether primary trabeculectomy or primary medical treatment produces better outcomes in term of quality of life, clinical effectiveness, and safety in patients presenting with advanced glaucoma.
DESIGN
Pragmatic multicentre randomised controlled trial.
SETTING
27 secondary care glaucoma departments in the UK.
PARTICIPANTS
453 adults presenting with newly diagnosed advanced open angle glaucoma in at least one eye (Hodapp classification) between 3 June 2014 and 31 May 2017.
INTERVENTIONS
Mitomycin C augmented trabeculectomy (n=227) and escalating medical management with intraocular pressure reducing drops (n=226) MAIN OUTCOME MEASURES: Primary outcome: vision specific quality of life measured with Visual Function Questionnaire-25 (VFQ-25) at 24 months.
SECONDARY OUTCOMES
general health status, glaucoma related quality of life, clinical effectiveness (intraocular pressure, visual field, visual acuity), and safety.
RESULTS
At 24 months, the mean VFQ-25 scores in the trabeculectomy and medical arms were 85.4 (SD 13.8) and 84.5 (16.3), respectively (mean difference 1.06, 95% confidence interval -1.32 to 3.43; P=0.38). Mean intraocular pressure was 12.4 (SD 4.7) mm Hg for trabeculectomy and 15.1 (4.8) mm Hg for medical management (mean difference -2.8 (-3.8 to -1.7) mm Hg; P<0.001). Adverse events occurred in 88 (39%) patients in the trabeculectomy arm and 100 (44%) in the medical management arm (relative risk 0.88, 95% confidence interval 0.66 to 1.17; P=0.37). Serious side effects were rare.
CONCLUSION
Primary trabeculectomy had similar quality of life and safety outcomes and achieved a lower intraocular pressure compared with primary medication.
TRIAL REGISTRATION
Health Technology Assessment (NIHR-HTA) Programme (project number: 12/35/38). ISRCTN registry: ISRCTN56878850.
Topics: Aged; Female; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Male; Middle Aged; Quality of Life; Surveys and Questionnaires; Trabeculectomy; United Kingdom; Visual Acuity
PubMed: 33980505
DOI: 10.1136/bmj.n1014 -
Ophthalmology Dec 2022To report 5-year treatment outcomes in the Primary Tube Versus Trabeculectomy (PTVT) Study. (Randomized Controlled Trial)
Randomized Controlled Trial
PURPOSE
To report 5-year treatment outcomes in the Primary Tube Versus Trabeculectomy (PTVT) Study.
DESIGN
Multicenter randomized clinical trial.
PARTICIPANTS
A total of 242 eyes of 242 patients with medically uncontrolled glaucoma and no previous incisional ocular surgery, including 125 patients in the tube group and 117 patients in the trabeculectomy group.
METHODS
Patients were enrolled at 16 clinical centers and randomly assigned to treatment with a tube shunt (350-mm Baerveldt glaucoma implant) or trabeculectomy with mitomycin C (MMC) (0.4 mg/ml for 2 minutes).
MAIN OUTCOME MEASURES
The primary outcome measure was the rate of surgical failure, defined as intraocular pressure (IOP) > 21 mmHg or reduced < 20% from baseline, IOP ≤ 5 mmHg, reoperation for glaucoma, or loss of light perception. Secondary outcome measures included IOP, glaucoma medical therapy, and visual acuity.
RESULTS
The cumulative probability of failure after 5 years of follow-up was 42% in the tube group and 35% in the trabeculectomy group (P = 0.21; hazard ratio = 1.31; 95% confidence interval = 0.86-2.01). At 5 years, IOP (mean ± standard deviation) was 13.4 ± 3.5 mmHg in the tube group and 13.0 ± 5.2 mmHg in the trabeculectomy group (P = 0.52), and the number of glaucoma medications (mean ± standard deviation) was 2.2 ± 1.3 in the tube group and 1.3 ± 1.4 in the trabeculectomy group (P < 0.001).
CONCLUSIONS
Trabeculectomy with MMC and tube shunt surgery produced similar IOPs after 5 years of follow-up in the PTVT Study, but fewer glaucoma medications were required after trabeculectomy. No significant difference in the rate of surgical failure was observed between the 2 surgical procedures at 5 years.
Topics: Humans; Trabeculectomy; Follow-Up Studies; Glaucoma Drainage Implants; Glaucoma; Intraocular Pressure; Mitomycin; Treatment Outcome
PubMed: 35835337
DOI: 10.1016/j.ophtha.2022.07.003 -
Lancet (London, England) Apr 2019Primary open angle glaucoma and ocular hypertension are habitually treated with eye drops that lower intraocular pressure. Selective laser trabeculoplasty is a safe... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Primary open angle glaucoma and ocular hypertension are habitually treated with eye drops that lower intraocular pressure. Selective laser trabeculoplasty is a safe alternative but is rarely used as first-line treatment. We compared the two.
METHODS
In this observer-masked, randomised controlled trial treatment-naive patients with open angle glaucoma or ocular hypertension and no ocular comorbidities were recruited between 2012 and 2014 at six UK hospitals. They were randomly allocated (web-based randomisation) to initial selective laser trabeculoplasty or to eye drops. An objective target intraocular pressure was set according to glaucoma severity. The primary outcome was health-related quality of life (HRQoL) at 3 years (assessed by EQ-5D). Secondary outcomes were cost and cost-effectiveness, disease-specific HRQoL, clinical effectiveness, and safety. Analysis was by intention to treat. This study is registered at controlled-trials.com (ISRCTN32038223).
FINDINGS
Of 718 patients enrolled, 356 were randomised to the selective laser trabeculoplasty and 362 to the eye drops group. 652 (91%) returned the primary outcome questionnaire at 36 months. Average EQ-5D score was 0·89 (SD 0·18) in the selective laser trabeculoplasty group versus 0·90 (SD 0·16) in the eye drops group, with no significant difference (difference 0·01, 95% CI -0·01 to 0·03; p=0·23). At 36 months, 74·2% (95% CI 69·3-78·6) of patients in the selective laser trabeculoplasty group required no drops to maintain intraocular pressure at target. Eyes of patients in the selective laser trabeculoplasty group were within target intracoluar pressure at more visits (93·0%) than in the eye drops group (91·3%), with glaucoma surgery to lower intraocular pressure required in none versus 11 patients. Over 36 months, from an ophthalmology cost perspective, there was a 97% probability of selective laser trabeculoplasty as first treatment being more cost-effective than eye drops first at a willingness to pay of £20 000 per quality-adjusted life-year gained.
INTERPRETATION
Selective laser trabeculoplasty should be offered as a first-line treatment for open angle glaucoma and ocular hypertension, supporting a change in clinical practice.
FUNDING
National Institute for Health Research, Health and Technology Assessment Programme.
Topics: Aged; Antihypertensive Agents; Female; Glaucoma, Open-Angle; Humans; Laser Therapy; Male; Middle Aged; Ocular Hypertension; Ophthalmic Solutions; Quality of Life; Trabeculectomy; Treatment Outcome
PubMed: 30862377
DOI: 10.1016/S0140-6736(18)32213-X -
BMJ Open Apr 2023To compare the efficacy and safety of tube shunt implantation with trabeculectomy in the treatment of patients with glaucoma. (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To compare the efficacy and safety of tube shunt implantation with trabeculectomy in the treatment of patients with glaucoma.
METHODS
A systematic literature search was performed for studies comparing tube with trabeculectomy in patients with glaucoma (final search date: 27 February 2022). Comparisons between tube and trabeculectomy were grouped by the type of tube (Ahmed, Baerveldt, Ex-PRESS and XEN). The primary endpoints included intraocular pressure (IOP), IOP reduction (IOPR), IOPR percentage (IOPR%), complete success rate (CSR), qualified success rate (QSR) and adverse events (AEs).
RESULTS
Forty-nine studies were included in this meta-analysis and presented data for 3795 eyes (Ahmed: 670, Baerveldt: 561, Ex-PRESS: 473, XEN: 199, trabeculectomy: 1892). Ahmed and Ex-PRESS were similar to trabeculectomy in terms of IOP outcomes and success rate (Ahmed vs trabeculectomy: IOPR%: mean difference (MD)=1.34 (-5.35, 8.02), p=0.69; Ex-PRESS vs trabeculectomy: IOPR%: MD=0.12 (-3.07, 3.31), p=0.94). The IOP outcomes for Baerveldt were worse than those for trabeculectomy (IOPR%: MD=-7.51 (-10.68, -4.35), p<0.00001), but the QSR was higher. No significant difference was shown for the CSR. XEN was worse than trabeculectomy in terms of IOP outcomes (IOPR%: MD=-7.87 (-13.55, -2.18), p=0.007), while the success rate was similar. Ahmed and Ex-PRESS had a lower incidence of AEs than trabeculectomy. Baerveldt had a lower incidence of bleb leakage/wound leakage, hyphaema and hypotonic maculopathy than trabeculectomy but a higher incidence of concurrent cataracts, diplopia/strabismus and tube erosion. The incidence of AEs was similar for the XEN and trabeculectomy procedures.
CONCLUSION
Compared with trabeculectomy, both Ahmed and Ex-PRESS appear to be associated with similar ocular hypotensive effects and lower incidences of AEs. However, Baerveldt and XEN cannot achieve sufficient reductions in IOP outcomes similar to those of trabeculectomy.
PROSPERO REGISTRATION NUMBER
CRD42021257852.
Topics: Humans; Trabeculectomy; Glaucoma Drainage Implants; Treatment Outcome; Glaucoma; Intraocular Pressure
PubMed: 37080625
DOI: 10.1136/bmjopen-2022-065921 -
The British Journal of Ophthalmology Jul 2004
Topics: Antimetabolites; Cicatrix; Clinical Competence; Fluorouracil; Glaucoma; Humans; Mitomycin; Trabeculectomy
PubMed: 15205223
DOI: 10.1136/bjo.2004.040055 -
Clinical & Experimental Optometry Mar 2017Trabeculectomy is the most common surgical procedure for the management of glaucoma, which may significantly influence ocular biometry. Axial length and anterior chamber... (Review)
Review
Trabeculectomy is the most common surgical procedure for the management of glaucoma, which may significantly influence ocular biometry. Axial length and anterior chamber depth tend to decrease, while crystalline lens and choroidal thickness increase post-operatively. An increase in with-the-rule astigmatism is also observed after the procedure. Such biometric changes affect intraocular lens power calculation even years after the procedure. Non-contact biometric methods and postponing cataract surgery after trabeculectomy could reduce calculation errors associated with surgically induced alterations in ocular biometrics.
Topics: Anterior Chamber; Axial Length, Eye; Biometry; Cataract Extraction; Choroid; Cornea; Humans; Lens, Crystalline; Trabeculectomy
PubMed: 27686794
DOI: 10.1111/cxo.12477 -
The Cochrane Database of Systematic... Mar 2023Glaucoma is an optic neuropathy that leads to visual field defects and vision loss. It is the second leading cause of irreversible blindness in the world. Treatment for... (Review)
Review
BACKGROUND
Glaucoma is an optic neuropathy that leads to visual field defects and vision loss. It is the second leading cause of irreversible blindness in the world. Treatment for glaucoma aims to reduce intraocular pressure (IOP) to slow or prevent further vision loss. IOP can be lowered with medications, laser, or incisional surgery. Trabeculectomy is a surgical approach which lowers IOP by shunting aqueous humor to a subconjunctival bleb. Device-modified trabeculectomy techniques are intended to improve the durability and safety of this bleb-forming surgery. Trabeculectomy-modifying devices include the Ex-PRESS, the XEN Gel Stent, the PreserFlo MicroShunt, as well as antifibrotic materials such as Ologen, amniotic membrane, expanded polytetrafluoroethylene (ePTFE) membrane, Gelfilm and others. However, the comparative effectiveness and safety of these devices are uncertain.
OBJECTIVES
To evaluate the benefits and harms of different devices as adjuncts to trabeculectomy on IOP control in eyes with glaucoma compared to standard trabeculectomy.
SEARCH METHODS
We used standard, extensive Cochrane search methods. The latest search was August 2021.
SELECTION CRITERIA
We included randomized controlled trials in participants with glaucoma comparing device-modified trabeculectomy techniques with standard trabeculectomy. We included studies that used antimetabolites in either or both treatment groups.
DATA COLLECTION AND ANALYSIS
We used standard Cochrane methods. Our primary outcomes were 1. change in IOP and 2. mean postoperative IOP at one year. Our secondary outcomes were 3. mean change in IOP from baseline, 4. mean postoperative IOP at any time point, 5. mean best-corrected visual acuity (BCVA), 6. visual field change, 7. quality of life, 8. proportion of participants who are drop-free at one year, 9. mean number of IOP lowering medications at one year, and 10. proportion of participants with complications.
MAIN RESULTS
Eight studies met our inclusion criteria, of which seven were full-length journal articles and one was a conference abstract. The eight studies included 961 participants with glaucoma, and compared two types of devices implanted during trabeculectomy versus standard trabeculectomy. Seven studies (462 eyes, 434 participants) used the Ex-PRESS, and one study (527 eyes, 527 participants) used the PreserFlo MicroShunt. No studies using the XEN Gel Stent implantation met our criteria. The studies were conducted in North America, Europe, and Africa. Planned follow-up periods ranged from six months to five years. The studies were reported poorly, which limited our ability to judge risk of bias for many domains. None of the studies explicitly masked outcome assessment. We rated seven studies at high risk of detection bias. Low-certainty of evidence from five studies showed that using the Ex-PRESS plus trabeculectomy compared with standard trabeculectomy may be associated with a slightly lower IOP at one year (mean difference (MD) -1.76 mmHg, 95% confidence interval (CI) -2.81 to -0.70; 213 eyes). Moderate-certainty of evidence from one study showed that using the PreserFlo MicroShunt may be associated with a slightly higher IOP than standard trabeculectomy at one year (MD 3.20 mmHg, 95% CI 2.29 to 4.11). Participants who received standard trabeculectomy may have a higher risk of hypotony compared with those who received device-modified trabeculectomy, but the evidence is uncertain (RR 0.73, 95% CI 0.46 to 1.17; I² = 38%; P = 0.14). In the subgroup of participants who received the PreserFlo MicroShunt, there was a lower risk of developing hypotony or shallow anterior chamber compared with those receiving standard trabeculectomy (RR 0.44, 95% CI 0.25 to 0.79; 526 eyes). Device-modified trabeculectomy may lead to less subsequent cataract surgery within one year (RR 0.46, 95% CI 0.27 to 0.80; I² = 0%).
AUTHORS' CONCLUSIONS
Use of an Ex-PRESS plus trabeculectomy may produce greater IOP reduction at one-year follow-up than standard trabeculectomy; however, due to potential biases and imprecision in effect estimates, the certainty of evidence is low. PreserFlo MicroShunt may be inferior to standard trabeculectomy in lowering IOP. However, PreserFlo MicroShunt may prevent postoperative hypotony and bleb leakage. Overall, device-modified trabeculectomy appears associated with a lower risk of cataract surgery within five years compared with standard trabeculectomy. Due to various limitations in the design and conduct of the included studies, the applicability of this evidence synthesis to other populations or settings is uncertain. Further research is needed to determine the effectiveness and safety of other devices in subgroup populations, such as people with different types of glaucoma, of various races and ethnicity, and with different lens types (e.g. phakic, pseudophakic).
Topics: Humans; Cataract; Glaucoma; Intraocular Pressure; Quality of Life; Randomized Controlled Trials as Topic; Trabeculectomy
PubMed: 36912740
DOI: 10.1002/14651858.CD010472.pub3 -
Asia-Pacific Journal of Ophthalmology... 2016Primary angle-closure glaucoma (PACG) is a progressive optic nerve degeneration and is defined as a glaucomatous optic neuropathy with associated characteristic... (Review)
Review
Primary angle-closure glaucoma (PACG) is a progressive optic nerve degeneration and is defined as a glaucomatous optic neuropathy with associated characteristic enlargement of optic disc cupping and visual field loss that is secondary to ocular hypertension caused by closure of the drainage angle. Angle closure is caused by appositional approximation or adhesion between the iris and the trabecular meshwork. The main treatment strategy for PACG lies in the reduction of intraocular pressure, reopening of the closed angle, and possible prevention of further angle closure. There is no universally agreed best surgical treatment for PACG. Trabeculectomy, goniosynechialysis (GSL), glaucoma implant, and cyclodestructive procedures are effective surgical options. Each of them plays an important role in the management of PACG with its own pros and cons. Accumulating evidence is available to show the effectiveness of visually significant and visually nonsignificant cataract extraction in the treatment of PACG. Trabeculectomy and GSL are often combined with cataract extraction, which may offer additional pressure control benefits to patients with PACG. This review article will discuss laser peripheral iridotomy, argon laser peripheral iridoplasty, and surgeries such as GSL, phacoemulsification, and phaco plus glaucoma surgeries that lower intraocular pressure and also alter the anterior segment and/or drainage angle anatomy. Currently, glaucoma implants and cyclodestruction are mainly reserved for PACG patients who have failed previous filtering operations. Their role as initial surgical treatment for PACG will not be discussed.
Topics: Antihypertensive Agents; Combined Modality Therapy; Disease Management; Glaucoma Drainage Implants; Glaucoma, Angle-Closure; Humans; Iridectomy; Laser Therapy; Ocular Hypertension; Optic Nerve Diseases; Phacoemulsification; Trabeculectomy
PubMed: 26886121
DOI: 10.1097/APO.0000000000000180 -
Acta Ophthalmologica Aug 2022To assess surgical success and the post-operative development of intraocular pressure between XEN45 gelstent, Preserflo MicroShunt and trabeculectomy with mitomycin C.
PURPOSE
To assess surgical success and the post-operative development of intraocular pressure between XEN45 gelstent, Preserflo MicroShunt and trabeculectomy with mitomycin C.
METHODS
Data from 105 eyes from 105 patients of matched cases with refractory open-angle glaucoma, who underwent surgery between January 2019, and August 2020, were evaluated. Patients underwent either stand-alone XEN gelstent insertion with Mitomycin C, stand-alone Preserflo with Mitomycin C or trabeculectomy with Mitomycin C. The primary outcome was the proportion of complete surgical success at 6 months post-operatively (i.e. intraocular pressure between 5mmHg and 18mmHg, no revision surgery, no loss of light perception and no post-operative pharmaceutical antiglaucomatous treatment). The reduction of intraocular pressure after 6 months, the classes of antiglaucomatous medication used post-operatively, best-corrected visual acuity, spherical refractive errors and astigmatism were assessed as secondary outcomes.
RESULTS
We included 35 eyes in each group. After 6-month follow-up, complete success was 73.5% [95%-CI: 57.9%-89.2%] in the trabeculectomy group, 51.4% [95%-CI: 34.0%-68.8%] in the XEN group and 74.2% [95%-CI: 57.9%-90.5%] in the Preserflo group (p = 0.08). Regarding secondary outcomes, the reduction of intraocular pressure was 12.1 ± 7.9 mmHg in the trabeculectomy group and was thereby 5.8 [95%-CI: 2.2-9.6] mmHg greater compared with the XEN group (p < 0.001) and 4.8 [95%-CI: 0.9-8.7] mmHg higher than the Preserflo group (p = 0.01).
CONCLUSIONS
No statistically significant differences were found between trabeculectomy, XEN45 gelstent implantation and Preserflo MicroShunt implantation regarding surgical success after 6 months. Yet reduction in intraocular pressure was significantly higher in the trabeculectomy group. However, all three interventions resulted in sufficiently low post-operative intraocular pressure and may therefore be considered individually for glaucoma treatment.
Topics: Follow-Up Studies; Glaucoma, Open-Angle; Humans; Intraocular Pressure; Mitomycin; Retrospective Studies; Tonometry, Ocular; Trabeculectomy; Treatment Outcome
PubMed: 34626093
DOI: 10.1111/aos.15042