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

INTERVENTION: 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 Corrected Visual Acuity (BCVA), Intraocular Pressure (IOP), ophthalmic examination with slit lamp, and fundoscopy. The cataract status will be graded by the Lens Opacities Classification System III (LOC III). Colour fundus photography, Optical Coherence Tomography (OCT line‐scan), and optical coherence tomography angiography (OCTA) examinations of the macula will be performed. A quality of life questionnaire (NEI VFQ‐25) will be administered. During baseline visit (up to 2 weeks or on the same day prior to cataract surgery), eligible patients will be randomised by a computer programme to receive either intravitreal aflibercept 2.0mg (Group A) or dexamethasone 0.7mg implant (Group B) injection at a 1:1 ratio. Patients will receive the first intravitreal injection according to their randomised group immediately following cataract surgery in the operating theatre. In the event of complicated cataract surgery where there is rupture of the posterior capsule or loss of vitreous, the patient will be withdrawn from the study without injection of study medication. As a routine, the dressing will remain intact until postoperative day 1 before starting to apply chloramphenicol 0.5% and dexamethasone 0.1% eye drops six times daily and tapered over 4 weeks. At each monthly follow‐up visit (until 12 months), patients will be assessed on BCVA, IOP, ophthalmic examination, OCT (line‐scan) and OCTA. Color fundus photographs will be taken at 3‐month intervals. NEI VFQ‐25 questionnaire will be administ CONDITION: 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 PRIMARY OUTCOME: 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 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 SECONDARY OUTCOME: ; 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;