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The Cochrane Database of Systematic... Sep 2023Ocular discomfort is the leading cause of permanent discontinuation of soft contact lens (SCL) wear. Silicone hydrogel and hydrogel materials are the two major... (Review)
Review
BACKGROUND
Ocular discomfort is the leading cause of permanent discontinuation of soft contact lens (SCL) wear. Silicone hydrogel and hydrogel materials are the two major categories of SCLs, with silicone hydrogel materials being newer and more breathable than hydrogel materials. Whether comfort is associated with SCL material is controversial despite numerous studies. Similarly, the difference between these materials in terms of safety outcomes (e.g. frequency of microbial keratitis) is unclear.
OBJECTIVES
To evaluate the comparative effectiveness and safety of silicone hydrogel compared with hydrogel SCLs on self-reported comfort, dry eye test results, and adverse events in SCL-wearing adults 18 years of age or older.
SEARCH METHODS
The Cochrane Eyes and Vision Information Specialist searched the electronic databases for randomized controlled trials (RCTs). There were no restrictions on language or date of publication. We searched the Cochrane Central Register of Controlled Trials (CENTRAL, including the Cochrane Eyes and Vision Trials Register; 2022, Issue 6), MEDLINE Ovid, Embase.com, PubMed, LILACS (Latin American and Caribbean Health Science Information database), ClinicalTrials.gov, and World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). We also searched the reference lists of identified studies, review articles, and guidelines for information about relevant studies that may not have been identified by our search strategy. Furthermore, we contacted investigators regarding ongoing trials. The most recent database search was conducted on 24 June 2022.
SELECTION CRITERIA
Our search selection criteria included RCTs, quasi-RCTs, and cross-over RCTs.
DATA COLLECTION AND ANALYSIS
We applied standard Cochrane methodology.
MAIN RESULTS
We included seven parallel-group RCTs conducted in the USA, the UK, Australia, Germany, India, and Turkey. A total of 1371 participants were randomized. The duration of SCL wear ranged from one to 52 weeks. Study characteristics and risk of bias The median number of participants per trial was 120 (interquartile range: 51 to 314), and the average age ranged from 20.7 to 33.0 years. Women represented the majority of participants (range 55% to 74.9%; 5 RCTs). Collectively, the included trials compared eight different silicone hydrogel SCLs with three different hydrogel SCLs. Five trials compared daily disposable SCLs, and two compared extended wear SCLs (worn for seven days and six nights). New SCL wearers were enrolled in three trials. Two trials included both new and established SCL wearers, and two trials did not report participants' history of SCL use. Five trials were sponsored by industry. We judged the overall risk of bias to be 'high' or 'some concerns' for the safety and efficacy outcomes. Findings One trial reported Ocular Surface Disease Index (OSDI) results, with the evidence being very uncertain about the effects of SCL material on OSDI scores (mean difference -1.20, 95% confidence interval [CI] -10.49 to 8.09; 1 RCT, 47 participants; very low certainty evidence). Three trials reported visual analog scale comfort score results, with no clear difference in comfort between materials, but the evidence was of very low certainty; trial results could not be combined because the three trials reported results at different time points. The evidence is very uncertain about the effect of SCL material on discontinuation of contact lens wear (risk ratio [RR] 0.64, 95% CI 0.11 to 3.74; 1 RCT, 248 participants). None of the included trials reported Contact Lens Dry Eye Questionnaire (CLDEQ-8) or Standard Patient Evaluation of Eye Dryness (SPEED) scores. There was no evidence of a clinically meaningful difference (> 0.5 unit) between daily disposable silicone hydrogel and hydrogel SCLs in corneal staining, conjunctival staining, or conjunctival redness (very low certainty evidence). Adverse events Very low certainty evidence from two trials comparing daily disposable SCLs suggested no evidence of a difference between lens materials in the risk of vision-threatening adverse events at one to four weeks (RR 0.68, 95% CI 0.08 to 5.51; 2 RCTs, 368 participants). Two trials comparing extended wear SCLs indicated that hydrogel SCLs may have a 2.03 times lower risk of adverse events at 52 weeks compared with silicone hydrogel SCLs (RR 2.03, 95% CI 1.38 to 2.99; 815 participants), but the certainty of evidence was very low.
AUTHORS' CONCLUSIONS
The overall evidence for a difference between all included silicone hydrogel and hydrogel SCLs was of very low certainty, with most trials at high overall risk of bias. The majority of studies did not assess comfort using a validated instrument. There was insufficient evidence to support recommending one SCL material over the other. For extended wear, hydrogel SCL may have a lower risk of adverse events at 52 weeks compared to silicon hydrogel. Future well-designed trials are needed to generate high certainty evidence to further clarify differences in SCL material comfort and safety.
Topics: Adult; Female; Humans; Adolescent; Young Adult; Silicones; Hydrogels; Face; Contact Lenses, Hydrophilic; Patient Reported Outcome Measures; Randomized Controlled Trials as Topic
PubMed: 37724689
DOI: 10.1002/14651858.CD014791.pub2 -
The Cochrane Database of Systematic... Aug 2023Macular hole (MH) is a full-thickness defect in the central portion of the retina that causes loss of central vision. According to the usual definition, a large MH has a... (Review)
Review
BACKGROUND
Macular hole (MH) is a full-thickness defect in the central portion of the retina that causes loss of central vision. According to the usual definition, a large MH has a diameter greater than 400 µm at the narrowest point. For closure of MH, there is evidence that pars plana vitrectomy (PPV) with internal limiting membrane (ILM) peeling achieves better anatomical outcomes than standard PPV. PPV with ILM peeling is currently the standard of care for MH management; however, the failure rate of this technique is higher for large MHs than for smaller MHs. Some studies have shown that the inverted ILM flap technique is superior to conventional ILM peeling for the management of large MHs.
OBJECTIVES
To evaluate the clinical effectiveness and safety of pars plana vitrectomy with the inverted internal limiting membrane flap technique versus pars plana vitrectomy with conventional internal limiting membrane peeling for treating large macular holes, including idiopathic, traumatic, and myopic macular holes.
SEARCH METHODS
The Cochrane Eyes and Vision Information Specialist searched CENTRAL, MEDLINE, Embase, two other databases, and two trials registries on 12 December 2022.
SELECTION CRITERIA
We included randomized controlled trials (RCTs) that evaluated PPV with ILM peeling versus PPV with inverted ILM flap for treatment of large MHs (with a basal diameter greater than 400 µm at the narrowest point measured by optical coherence tomography) of any type (idiopathic, traumatic, or myopic).
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by Cochrane and assessed the certainty of the body of evidence using GRADE.
MAIN RESULTS
We included four RCTs (285 eyes of 275 participants; range per study 24 to 91 eyes). Most participants were women (63%), and of older age (range of means 59.4 to 66 years). Three RCTs were single-center trials, and the same surgeon performed all surgeries in two RCTs (the third single-center RCT did not report the number of surgeons). One RCT was a multicenter trial (three sites), and four surgeons performed all surgeries. Two RCTs took place in India, one in Poland, and one in Mexico. Maximum follow-up ranged from three months (2 RCTs) to 12 months (1 RCT). No RCTs reported conflicts of interest or disclosed financial support. All four RCTs enrolled people with large idiopathic MHs and compared conventional PPV with ILM peeling versus PPV with inverted ILM flap techniques. Variations in technique across the four RCTs were minimal. There was some heterogeneity in interventions: in two RCTs, all participants underwent combined cataract-PPV surgery, whereas in one RCT, some participants underwent cataract surgery after PPV (the fourth RCT did not mention cataract surgery). The critical outcomes for this review were mean best-corrected visual acuity (BCVA) and MH closure rates. All four RCTs provided data for meta-analyses of both critical outcomes. We assessed the risk of bias for both outcomes using the Cochrane risk of bias tool (RoB 2); there were some concerns for risk of bias associated with lack of masking of outcome assessors and selective reporting of outcomes in all RCTs. All RCTs reported postoperative BCVA values; only one RCT reported the change in BCVA from baseline. Based on evidence from the four RCTs, it is unclear if the inverted ILM flap technique compared with ILM peeling reduces (improves) postoperative BCVA measured on a logarithm of the minimum angle of resolution (logMAR) chart at one month (mean difference [MD] -0.08 logMAR, 95% confidence interval [CI] -0.20 to 0.05; P = 0.23, I = 65%; 4 studies, 254 eyes; very low-certainty evidence), but it may improve BCVA at three months or more (MD -0.17 logMAR, 95% CI -0.23 to -0.10; P < 0.001, I = 0%; 4 studies, 276 eyes; low-certainty evidence). PPV with an inverted ILM flap compared to PPV with ILM peeling probably increases the proportion of eyes achieving MH closure (risk ratio [RR] 1.10, 95% CI 1.02 to 1.18; P = 0.01, I = 0%; 4 studies, 276 eyes; moderate-certainty evidence) and type 1 MH closure (RR 1.31, 95% CI 1.03 to 1.66; P = 0.03, I² = 69%; 4 studies, 276 eyes; moderate-certainty evidence). One study reported that none of the 38 participants experienced postoperative retinal detachment.
AUTHORS' CONCLUSIONS
We found low-certainty evidence from four small RCTs that PPV with the inverted ILM flap technique is superior to PPV with ILM peeling with respect to BCVA gains at three or more months after surgery. We also found moderate-certainty evidence that the inverted ILM flap technique achieves more overall and type 1 MH closures. There is a need for high-quality multicenter RCTs to ascertain whether the inverted ILM flap technique is superior to ILM peeling with regard to anatomical and functional outcomes. Investigators should use the standard logMAR charts when measuring BCVA to facilitate comparison across trials.
Topics: Female; Humans; Male; Cataract; Multicenter Studies as Topic; Myopia; Retina; Retinal Perforations; Retrospective Studies; Tomography, Optical Coherence; Visual Acuity; Vitrectomy
PubMed: 37548231
DOI: 10.1002/14651858.CD015031.pub2 -
Frontiers in Medicine 2024This meta-analysis was conducted to collect all available data and estimate the relationship between refractive error and the risk of diabetic retinopathy (DR) in...
PURPOSE
This meta-analysis was conducted to collect all available data and estimate the relationship between refractive error and the risk of diabetic retinopathy (DR) in patients with diabetes, and to assess whether vision-threatening DR (VTDR) is associated with refractive error.
METHODS
We systematically searched several literature databases including PubMed, Embase, Cochrane Library, Web of Science, CNKI, CBM, Wan Fang Data, and VIP databases. Pooled odds ratios (OR) and 95% confidence intervals (CI) were calculated using fixed or random effects models. Four models were developed to assess the relationship between refractive error and the risk and DR, VTDR: hyperopia and DR, VTDR; myopia and DR, VTDR; spherical equivalent (SE per D increase) and DR, VTDR; and axial length (AL per mm increase) and DR, VTDR. The included literature was meta-analyzed using Stata 12.0 software, and sensitivity analysis was performed. Publication bias in the literature was evaluated using a funnel plot, Begg's test, and Egger's test.
RESULTS
A systematic search identified 3,198 articles, of which 21 (4 cohorts, 17 cross-sectional studies) were included in the meta-analysis. Meta-analysis showed that hyperopia was associated with an increased risk of VTDR ( 1.23; 95% : 1.08-1.39; = 0.001), but not with DR ( 1.05; 95% : 0.94-1.17; = 0.374). Myopia was associated with a reduced risk of DR ( 0.74; 95% : 0.61-0.90; = 0.003), but not with VTDR ( 1.08; 95% : 0.85-1.38; = 0.519). Every 1 diopter increase in spherical equivalent, there was a 1.08 increase in the odds ratio of DR ( 1.08; 95% : 1.05-1.10; <0.001), but not with VTDR ( 1.05; 95% : 1.00-1.10; = 0.06). AL per mm increase was significantly associated with a decreased risk of developing DR ( 0.77; 95% : 0.71-0.84; <0.001 and VTDR ( 0.63; 95% : 0.56-0.72; <0.001). Analysis of sensitivity confirmed the reliability of the study's findings.
CONCLUSION
This meta-analysis demonstrates hyperopia was associated with an increased risk of VTDR in diabetes patients. Myopia was associated with a reduced risk of DR. AL is an important influencing factor of refractive error. Every 1 mm increase in AL reduces the risk of DR by 23% and the risk of VTDR by 37%.
SYSTEMATIC REVIEW REGISTRATION
identifier: CRD42023413420.
PubMed: 38895184
DOI: 10.3389/fmed.2024.1354856 -
Seminars in Ophthalmology Apr 2024To summarize and analyze critically the scientific evidence focused on the effectiveness of the use of hydrophilic contact lenses (HCLs) in myopia control, as well as... (Review)
Review
PURPOSE
To summarize and analyze critically the scientific evidence focused on the effectiveness of the use of hydrophilic contact lenses (HCLs) in myopia control, as well as their impact on visual quality and the involvement on the accommodative and binocular function.
METHODS
This systematic review was developed selecting all original studies which evaluated HCLs for myopia control with follow-up of at least 1 year. Eligible randomized controlled trials (RCTs) were retrieved from PubMed MEDLINE and Scopus. Methodological quality of the studies was assessed using the Critical Appraisal Skills Programme (CASP) for RCTs.
RESULTS
The search provided a total of 276 articles, selecting 13 according to the inclusion and exclusion criteria. The majority of studies evaluating the effectiveness of HCL showed a good efficacy in myopia progression, providing a good quality of vision. The quality of these studies was found to be suitable according to the CASP tool. The accommodative and binocular function with these lenses was evaluated in few studies, reporting a trend to an increase in the accommodative response and exophoria in near vision, while maintaining good level of stereopsis. Aberrometry and pupillometry were only studied in one trial, in which the authors did not find changes in these variables after the use of a myopia control HCL.
CONCLUSIONS
There is a strong evidence about the effectiveness of different HCLs designs for slowing down myopia progression in children, providing all of them good levels of visual quality. However, there is still poor evidence about changes in accommodation and binocular function, as well as in pupil size and aberrometry with myopia control HCLs, being necessary more studies focused on this issue.
Topics: Child; Humans; Myopia; Contact Lenses, Hydrophilic; Depth Perception; Accommodation, Ocular; Exotropia; Refraction, Ocular
PubMed: 37853677
DOI: 10.1080/08820538.2023.2271063 -
European Journal of Ophthalmology Nov 2023Optical coherence tomography angiography (OCTA) is a noninvasive imaging method that can be used for the staging of diabetic retinopathy. In addition, alterations in... (Review)
Review
BACKGROUND
Optical coherence tomography angiography (OCTA) is a noninvasive imaging method that can be used for the staging of diabetic retinopathy. In addition, alterations in OCTA parameters can precede the clinical fundus changes. In this review, we aimed to assess the accuracy of OCTA in diagnosis and staging of diabetic retinopathy.
METHODS
Two independent reviewers participated in the literature search using electronic databases (PubMed, Embase, Cochrane Library Central Register of Controlled Trials, ISI, and Scopus) from inception till December 2020. The heterogeneity of data was assessed by Q statistics, Chi-square test and I index.
RESULTS
Forty-four articles published from 2015 to the end of 2020 were included in this meta-analysis. Of these, 27 were case-control studies, 9 were case series, and 8 were cohort studies. In total, 4284 eyes of 3553 patients were assessed in this study OCTA could differentiate diabetic retinopathy from diabetes without diabetic retinopathy with a sensitivity of 88% (95% CI: 85% to 92%) and specificity of 88% (95% CI: 85% to 91%). In addition, it could differentiate proliferative diabetic retinopathy from non-proliferative diabetic retinopathy with a sensitivity of 91% (95% CI: 86% to 95%) and specificity of 91% (95% CI:86% to 96%). The sensitivity of OCTA for diagnosing diabetic retinopathy was increased by the size of scan (3 × 3 mm: 85%; 6 × 6 mm: 91%, 12 × 12 mm: 96%).
CONCLUSION
OCTA, as a non-invasive method, has acceptable sensitivity and specificity for diagnosis and classification of diabetic retinopathy. A larger scan size is associated with more sensitivity for discriminating diabetic retinopathy.
PubMed: 37013361
DOI: 10.1177/11206721231167458 -
Optometry and Vision Science : Official... Dec 2023Eye tracking is a promising method for objectively assessing functional visual capabilities, but its suitability remains unclear when assessing the vision of people with...
BACKGROUND
Eye tracking is a promising method for objectively assessing functional visual capabilities, but its suitability remains unclear when assessing the vision of people with vision impairment. In particular, accurate eye tracking typically relies on a stable and reliable image of the pupil and cornea, which may be compromised by abnormalities associated with vision impairment (e.g., nystagmus, aniridia).
OBJECTIVES
This study aimed to establish the degree to which video-based eye tracking can be used to assess visual function in the presence of vision impairment.
DATA SOURCES
A systematic review was conducted using PubMed, EMBASE, and Web of Science databases, encompassing literature from inception to July 2022.
STUDY ELIGIBILITY CRITERIA, PARTICIPANTS, AND INTERVENTIONS
Studies included in the review used video-based eye tracking, included individuals with vision impairment, and used screen-based tasks unrelated to practiced skills such as reading or driving.
STUDY APPRAISAL AND SYNTHESIS METHODS
The included studies were assessed for quality using the Strengthening the Reporting of Observational Studies in Epidemiology assessment tool. Data extraction and synthesis were performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.
RESULTS
Our analysis revealed that five common tests of visual function were used: (i) fixation stability, (ii) smooth pursuit, (iii) saccades, (iv) free viewing, and (v) visual search. The studies reported considerable success when testing individuals with vision impairment, yielding usable data from 96.5% of participants.
LIMITATIONS
There was an overrepresentation of conditions affecting the optic nerve or macula and an underrepresentation of conditions affecting the anterior segment or peripheral retina.
CONCLUSIONS AND IMPLICATIONS OF KEY FINDINGS
The results offer promise for the use of eye tracking to assess the visual function of a considerable proportion of those with vision impairment. Based on the findings, we outline a framework for how eye tracking can be used to test visual function in the presence of vision impairment.
Topics: Humans; Eye-Tracking Technology; Nystagmus, Pathologic; Retina; Pursuit, Smooth
PubMed: 38165789
DOI: 10.1097/OPX.0000000000002088 -
PeerJ 2024To evaluate the efficacy and safety of Brolucizumab for neovascular age-related macular degeneration (n-AMD) through a systematic review and meta-analysis. (Meta-Analysis)
Meta-Analysis
BACKGROUND
To evaluate the efficacy and safety of Brolucizumab for neovascular age-related macular degeneration (n-AMD) through a systematic review and meta-analysis.
MATERIALS AND METHODS
Cochrane, PubMed, Embase, and Web of Science databases were comprehensively searched for relevant studies. Stata and RevMan5.4 were applied for meta-analysis and risk of bias assessment. Data on the best-corrected visual acuity (BCVA), central subfield thickness (CSFT), presence of intraretinal fluid (IRF) and/or subretinal fluid (SRF), participants with ≥1 serious adverse events, and participants with ≥1 adverse events were analyzed.
RESULTS
Six studies were finally included. Meta-analysis showed statistical differences in BCVA [SMD = -0.65, 95% CI [-0.17 to -0.23], < 0.05], the presence of IRF and/or SRF [RR = 0.67, 95% CI [0.56-0.79], < 0.05], and the safety of participants with ≥1 serious adverse events [RR = 0.57, 95% CI [0.39-0.84], < 0.05] between the experimental group and the control group. However, no statistical differences were observed in CSFT [SMD = -1.16, 95% CI [-2.79 to 0.47], > 0.05] or the safety of participants with ≥1 adverse events [RR = 1.07, 95% CI [0.97-1.17], > 0.05].
CONCLUSIONS
Compared to other anti-VEGF drugs such as Aflibercept and Ranibizumab, intravitreal injection of 6 mg Brolucizumab is more effective and safer for n-AMD, especially in the presence of IRF and/or SRF, and for participants with ≥1 serious adverse events.
Topics: Humans; Angiogenesis Inhibitors; Antibodies, Monoclonal, Humanized; Intravitreal Injections; Macular Degeneration; Treatment Outcome; Visual Acuity; Wet Macular Degeneration
PubMed: 38915383
DOI: 10.7717/peerj.17561 -
Journal of Cataract and Refractive... May 2024Corneal crosslinking (CXL) is used for treating keratoconus and post-laser in situ keratomileusis ectasia. However, refractive surgery is not usually performed with... (Meta-Analysis)
Meta-Analysis Comparative Study
Corneal crosslinking (CXL) is used for treating keratoconus and post-laser in situ keratomileusis ectasia. However, refractive surgery is not usually performed with prophylactic CXL. Therefore, we performed a meta-analysis comparing outcomes of refractive surgeries with vs without prophylactic CXL. We systematically searched databases for studies comparing refractive surgeries for myopic correction with vs without prophylactic corneal crosslinking. Review Manager 5.4.1 was used to perform statistical analysis. We included 2820 eyes from 28 studies. Compared with refractive surgery alone, surgery with prophylactic CXL resulted in decreased central corneal thickness, corrected distance visual acuity logMAR, and safety and efficacy indices. There were no significant differences in postoperative uncorrected distance visual acuity of 20/20 or better at ≥12 months and other visual outcomes among both groups. More randomized controlled trials with standard crosslinking protocols are needed to analyze the prophylactic use of crosslinking with refractive surgeries.
Topics: Humans; Cross-Linking Reagents; Photosensitizing Agents; Keratomileusis, Laser In Situ; Riboflavin; Collagen; Visual Acuity; Myopia; Photorefractive Keratectomy; Photochemotherapy; Lasers, Excimer; Corneal Stroma; Ultraviolet Rays; Keratoconus; Corneal Surgery, Laser; Refraction, Ocular
PubMed: 38288954
DOI: 10.1097/j.jcrs.0000000000001405 -
Neurology(R) Neuroimmunology &... Sep 2023Glial fibrillary acidic protein (GFAP) antibodies can associate with an astrocytopathy often presenting as a meningoencephalitis. Visual involvement has been reported...
BACKGROUND AND OBJECTIVES
Glial fibrillary acidic protein (GFAP) antibodies can associate with an astrocytopathy often presenting as a meningoencephalitis. Visual involvement has been reported but scarcely defined. We describe 2 cases of GFAP astrocytopathy with predominant visual symptoms and present a systematic review of the literature.
METHODS
We describe 2 patients with GFAP astrocytopathy from our neurology department. We performed a systematic review of the literature according to PRISMA guidelines, including all patients with this disease and available clinical data, focusing on visual involvement.
RESULTS
Patient 1 presented with bilateral optic disc edema and severe sudden bilateral loss of vision poorly responsive to therapy. Patient 2 showed bilateral optic disc edema, headache, and mild visual loss with complete recovery after steroids. We screened 275 records and included 84 articles (62 case reports and 22 case series) for a total of 592 patients. Visual involvement was reported in 149/592 (25%), with either clinical symptoms or paraclinical test-restricted abnormalities. Bilateral optic disc edema was found in 80/159 (50%) of patients investigated with fundoscopy, among which 49/80 (61%) were asymptomatic. One hundred (100/592, 17%) reported visual symptoms, often described as blurred vision or transient visual obscurations. Optic neuritis was rare and diagnosed in only 6% of all patients with GFAP astrocytopathy, often without consistent clinical and paraclinical evidence to support the diagnosis. Four patients (including patient 1) manifested a severe, bilateral optic neuritis with poor treatment response. In patients with follow-up information, a relapsing disease course was more frequently observed in those with vs without visual involvement (35% vs 11%, = 0.0035, OR 3.6 [CI 1.44-8.88]).
DISCUSSION
Visual system involvement in GFAP astrocytopathy is common and heterogeneous, ranging from asymptomatic bilateral optic disc edema to severe bilateral loss of vision, but optic neuritis is rare. GFAP CSF antibody testing should be considered in patients with encephalitis/meningoencephalitis or myelitis and bilateral optic disc edema, even without visual symptoms, and in patients with severe bilateral optic neuritis, especially when AQP4 antibodies are negative. Visual symptoms might associate with a higher relapse risk and help to identify patients who may require chronic immunosuppression.
Topics: Humans; Papilledema; Glial Fibrillary Acidic Protein; Meningoencephalitis; Optic Neuritis; Antibodies
PubMed: 37582612
DOI: 10.1212/NXI.0000000000200146 -
Eye (London, England) Mar 2024Visual fields under mesopic and scotopic lighting are increasingly being used for macular functional assessment. This review evaluates its statistical significance and... (Review)
Review
Visual fields under mesopic and scotopic lighting are increasingly being used for macular functional assessment. This review evaluates its statistical significance and clinical relevance, and the optimal testing protocol for early/intermediate age-related macular degeneration (AMD). PubMed and Embase were searched from inception to 14/05/2022. All quality assessments were performed according to GRADE guidelines. The primary outcome was global mean sensitivity (MS), further meta-analysed by: AMD classification scheme, device, test pattern, mesopic/scotopic lighting, stimuli size/chromaticity, pupil dilation, testing radius (area), background luminance, adaptation time, AMD severity, reticular pseudodrusen presence, and follow-up visit. From 1489 studies screened, 42 observational study results contributed to the primary meta-analysis. Supported by moderate GRADE certainty of the evidence, global MS was significantly reduced across all devices under mesopic and scotopic lighting with large effect size (-0.9 [-1.04, -0.75] Hedge's g, P < 0.0001). The device (P < 0.01) and lighting (P < 0.05) used were the only modifiable factors affecting global MS, whereby the mesopic MP-1 and MAIA produced the largest effect sizes and exceeded test-retest variabilities. Global MS was significantly affected by AMD severity (intermediate versus early AMD; -0.58 [-0.88, -0.29] Hedge's g or -2.55 [3.62, -1.47] MAIA-dB) and at follow-up visit (versus baseline; -0.62 [-0.84, -0.41] Hedge's g or -1.61[-2.69, -0.54] MAIA-dB). Magnitudes of retinal sensitivity changes in early/intermediate AMD are clinically relevant for the MP-1 and MAIA devices under mesopic lighting within the central 10° radius. Other factors including pupil dilation and dark adaptation did not significantly affect global MS in early/intermediate AMD.
PubMed: 38499857
DOI: 10.1038/s41433-024-03033-0