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
Conditions
Interventions
Eligible patients will be enrolled in the study after signing the informed consent form (ICF). Patients will be assessed for medical and ophthalmic history, HbA1c levels, blood pressure, Best Correcte
Sponsors
Chinese University of Hong Kong
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Any treatment-related adverse events measured from ophthalmic investigation and examination and/or clinical notes between baseline and 12 months 2. Number of injections measured from clinical notes or injection records between baseline and 12 months 3. Central Macular Thickness (CMT) measured using Spectral domain (SD) OCT (Spectralis; Heidelberg Engineering, Heidelberg, Germany) monthly between baseline and 12 months 4. Optical Coherence Tomography Angiography (OCTA) metrics at Superficial Capillary Plexus (SCP) and Deep Capillary Plexus (DCP) measured using OCTA monthly between baseline and 12 months: 4.1. Vessel density 4.2. Foveal Avascular Zone (FAZ) area 4.3. FAZ circularity 4.4. Fractal dimension 5. Patient-reported outcomes using the 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) quality of life questionnaire at baseline and 12 months 6. Types of treatment received measured from electronic medical records at 15, 18, 21, and 24 months 7. Frequency of treatments received measured from electronic medical records at 15, 18, 21, and 24 months 8. Best Corrected Visual Acuity (BCVA) measured using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts at 15, 18, 21, and 24 months 9. CMT measured using Spectral domain (SD) OCT (Spectralis; Heidelberg Engineering, Heidelberg, Germany) at 15, 18, 21, and 24 months 10. OCTA metrics at SCP and DCP measured using OCTA monthly at 15, 18, 21, and 24 months: 10.1. Vessel density 10.2. Foveal Avascular Zone (FAZ) area 10.3. FAZ circularity 10.4. Fractal dimension 11. Patient-reported outcomes using the NEI VFQ-25 questionnaire at 24 months | — |
Countries
Hong Kong
Outcome results
None listed