Implantable miniature telescope (IMT) for vision loss due to end-stage age-related macular degeneration.

BACKGROUND: Age-related macular degeneration (AMD) causes progressive and irreversible damage to the retina, resulting in loss of central vision. AMD is the third leading cause of irreversible visual impairment worldwide and the leading cause of blindness in industrialized countries. Since AMD is more common in older individuals, the number of affected individuals will increase significantly as the population ages. The implantable miniature telescope (IMT) is an ophthalmic device developed to improve vision in individuals who have lost vision due to AMD. Once implanted, the IMT is used to enlarge objects in the central visual field and focus them onto healthy areas of the retina not affected by AMD, allowing individuals to recognize objects that they otherwise could not see. It is unclear whether and how much the IMT can improve vision in individuals with end-stage AMD. OBJECTIVES: To assess the effectiveness and safety of the IMT in improving visual acuity and quality of life in people with late or advanced AMD. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2017, Issue 11); Ovid MEDLINE; Embase.com; PubMed; LILACS; AMED; Web of Science Conference Proceedings Citation Index-Science; OpenSIGLE; the metaRegister of Controlled Trials (mRCT) (last searched 27 June 2014); ClinicalTrials.gov; the ICTRP and the US Food and Drug Administration (FDA) Medical Devices database. The date of the search was 2 November 2017, with the exception of mRCT which is no longer in service. SELECTION CRITERIA: We planned to include randomized controlled trials (RCTs) and quasi-randomized trials that compared the IMT versus no IMT. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed all studies for inclusion, using standard methodological procedures expected by Cochrane. MAIN RESULTS: Our search yielded 1042 unique records. We removed irrelevant studies after screening titles and abstracts, and evaluated five full-text reports from four studies; three were non-randomized studies. There was one ongoing RCT that compared the OriLens intraocular telescope with standard low vision training in eyes with end-stage AMD. Results for this study are expected in 2020. AUTHORS' CONCLUSIONS: We found no RCT or quasi-RCT and can draw no conclusion about the effectiveness and safety of the IMT in improving visual acuity in individuals with late or advanced AMD. Since the IMT is typically implanted monocularly based upon which eye has better best-corrected distance visual acuity, randomization between eyes within an individual may not be acceptable. Studies are needed that compare outcomes between individuals randomized to the device versus individuals not implanted, at least during study follow-up, who serve as controls.

TREATMENT PATTERNS AND 2-YEAR VISION OUTCOMES WITH BEVACIZUMAB IN DIABETIC MACULAR EDEMA: An Analysis From a Large U.S. Integrated Health Care System.

PURPOSE: To assess health care utilization and vision outcomes over 2 years in patients receiving bevacizumab treatment in clinical practice for diabetic macular edema. METHODS: Patients with newly diagnosed diabetic macular edema who received an intravitreal bevacizumab injection within 12 months of initial diagnosis were identified from Kaiser Permanente's 350,000 patients with diabetes mellitus treated between 2008 and 2013. Snellen best-corrected visual acuity (BCVA), number of intravitreal injections, and patient characteristics were abstracted from the electronic record. The main outcome measure was change in BCVA. RESULTS: Three hundred and nine patients met the inclusion criteria and had 2 years of follow-up after their first bevacizumab injection. These patients had a mean of 3.1 injections (range, 1-17) during the 2-year follow-up. Mean BCVA improvement was 5.4 letters at 12 months and 5.3 letters at 24 months. Only 29.8% of patients demonstrated ≥3 lines of vision improvement from baseline, whereas 12.3% had ≥3 lines of vision loss from baseline at 24 months. CONCLUSION: This is the largest U.S. clinical practice-based study of bevacizumab use in diabetic macular edema. Consistent with national studies, the frequency of injection was low. Average BCVA improvement was lower than in anti-vascular endothelial growth factor trials. Significant BCVA improvement was achieved in approximately 30% of patients with newly diagnosed diabetic macular edema.

Intravitreal bevacizumab and ranibizumab for age-related macular degeneration a multicenter, retrospective study.

OBJECTIVE: To compare visual acuity (VA) outcomes after bevacizumab or ranibizumab treatment for AMD. DESIGN: Comparative, retrospective case series. PARTICIPANTS: We followed 452 patients in a retrospective study of exudative AMD treated with anti-vascular endothelial growth factor drugs; 324 patients were treated with bevacizumab and 128 patients with ranibizumab. METHODS: All treatment-naïve patients who received either bevacizumab or ranibizumab were followed for 1 year. Baseline characteristics and VA were recorded using standard descriptive statistics. MAIN OUTCOME MEASURES: Visual acuity. RESULTS: At 12 months, the distribution of VA improved in both groups with 22.9% of bevacizumab and 25.0% of ranibizumab attaining >or=20/40. Improvement in vision was observed in 27.3% of the bevacizumab group and 20.2% of the ranibizumab group. The mean number of injections at 12 months was 4.4 for bevacizumab and 6.2 for ranibizumab. There were 8 (2%) deaths in the bevacizumab group and 4 (3%) in the ranibizumab group. Two patients developed endophthalmitis in the bevacizumab group and the ranibizumab group. The bevacizumab group had slightly worse acuity at baseline, but both groups showed improvement and stability of vision over time. CONCLUSIONS: Both treatments seem to be effective in stabilizing VA loss. There was no difference in VA outcome between the 2 treatment groups. Because the study is a nonrandomized comparison, selection bias could mask a true treatment difference. Results from the Comparison of the Age-related Macular Degeneration Treatment Trials will provide more definitive information about the comparative effectiveness of these drugs.