Research Appraisals
Evidence-based critical appraisals of the latest medical research, systematically evaluated using Oxford CEBM methodology.
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PloS one
Long term evaluation of the safety and efficacy of local cooling anesthesia during intravitreal injections: The COOL-2 Trial
BACKGROUND/OBJECTIVE: To evaluate the safety and effectiveness of a medical device providing cooling anesthesia to the eye as local anesthesia for intravitreal (IVT) injections. SUBJECTS/METHODS: As a multicenter, open label, dose escalation clinical trial, subjects receiving at least 3 IVT injections in the study eye were recruited to participate. All patients received subconjunctival lidocaine as their anesthesia for previous IVT injections. Subjects receiving IVT injections were assigned (non-randomized) to four groups in which the cooling device was applied to the conjunctiva at the location of the intravitreal injection: Group 1: -10˚C for 20 seconds; Group 2: -15˚C for 10 seconds; Group 3: -15˚C for 15 seconds; and Group 4: -15˚C for 20 seconds. The primary outcome was pain during IVT injection assessed by a visual analog scale (0-10). RESULTS: Eighty subjects were enrolled at 2 sites. The mean number of prior IVT injections was 20.3 for Group 2 and 15.0 for Group 3. Pain was significantly less for the 10 second vs the 15 second application (2.2 vs 3.6, p = 0.0255). The mean pain score was lower for Group 2 (-15°C for 10 seconds) ranging a score of 1.0 to 2.9 across the study visits, compared with Group 3 (-15°C for 15 seconds) with a mean range of 3.2 to 5.2 across the study visits. Treatment order (visit) significantly decreased by 0.10 pain units per visit (p = 0.0002). Punctate epithelial erosions (PEE) were reported in 20 of 56 eyes (35.7%) in Group 2, none were reported in Group 3. CONCLUSION: Cooling anesthesia device reduced the severity of pain associated with IVT injection during the procedure, although mild and transient PEE may be associated with treatment. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT03956797.
13 June 2026
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Remote Management of Patients With Diabetic Macular Edema Receiving Long-Term Intravitreal Anti-Vascular Endothelial Growth Factor Therapy (RE-SHINE Study): Protocol for a Real-World Study
BACKGROUND: Long-term intravitreal anti-vascular endothelial growth factor therapy is the gold standard for treating diabetic macular edema (DME). However, poor treatment adherence in real-world settings often leads to suboptimal visual outcomes. Evidence-based remote management strategies are required to bridge the gap between clinical protocols and patient self-management. OBJECTIVE: This study aims to describe a remote management program based on the Behavior Change Wheel model designed to increase treatment adherence and improve disease outcomes for patients with DME receiving long-term anti-vascular endothelial growth factor therapy, and to report the study protocol. METHODS: The RE-SHINE study was structured into three phases: theoretical modeling, digital platform development, and a validation cohort study. The intervention included a smartphone-based app providing personalized health education, self-monitoring of vision (Amsler grid), injection reminders, and direct communication with health care providers. The efficacy of the remote management model was tested in a real-world cohort study. Participants were assessed at baseline and at each follow-up visit over 12 months. The primary outcome measure was best-corrected visual acuity, and secondary outcome measures included central retinal thickness and treatment adherence (injection rate and follow-up frequency). RESULTS: A total of 1006 patients with DME underwent initial screening, and 958 (95.2%) patients met the inclusion criteria, with only 7 patients declining follow-up. We anticipate that the remote management system will be both feasible and acceptable for patients with DME. It is hypothesized that the intervention group would demonstrate significantly higher levels of treatment adherence and better visual preservation compared to the retrospective control group. In addition, we intend to assess the impact of the digital intervention on patient-reported outcomes, encompassing quality of life and self-efficacy. Participant recruitment began in September 2023 and was completed by the time of submission. The data analysis is yet to begin. The results are expected to be published in 2026. CONCLUSIONS: A Behavior Change Wheel-based remote management approach could be a scalable and sustainable method to enhance adherence in patients requiring long-term intravitreal therapy. If proven effective, this model could be integrated into routine ophthalmic care to mitigate the risk of vision loss due to undertreatment in DME.
7 Apr 2026
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