Optimised treatment for pre-existing diabetic macular oedema during cataract surgery

Not Applicable

• Conditions: Diabetic Macular Oedema in type 2 diabetic patients with visually significant cataract; Ear, Nose and Throat; Cataract, diabetic macular oedema, type 2 diabetes mellitus with ophthalmic complications

• Registration Number: ISRCTN18293240
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-25
• Last Update Posted: 8 February 2021
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

1. Aged =18 years
2. Type 2 diabetes mellitus
3. Visually significant cataract requiring surgery
4. Centre-involving DME at the time of study enrolment
5. Written informed consent

Exclusion Criteria

1. History of intravitreal injection of anti-Vascular Endothelial Growth Factor (anti-VEGF) within 1 month, steroids within 3 months, or macular focal/grid laser within 3 months, prior to cataract surgery
2. Macular oedema from causes other than diabetic maculopathy
3. Proliferative diabetic retinopathy requiring treatment, media opacities which affect fundus examination or Optical Coherence Tomography (OCT) measurements at baseline, or known significant macular ischemia demonstrated on fluorescein angiography or OCTA
4. Pre-existing glaucoma at the time of enrolment or previous history of steroid response (Intraocular Pressure (IOP) elevation >35 mmHg following steroid treatment)
5. Ocular disorders in the study eye at the time of enrollment that may confound interpretation of study results and compromise visual acuity (including retinal detachment, age-related macular degeneration, pathologic myopia, lamellar macular hole, and epiretinal membrane of the macula)
6. History of hypersensitivity to any intravitreal drugs
7. History of stroke or myocardial infarction within the 6 months prior to the screening visit
8. Pregnant or lactating

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Mean change in Best Corrected Visual Acuity (BCVA) measured using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts monthly between baseline and 12 months