Diabetic Retinopathy and OCT-A Changes Post-cataract Surgery

• Conditions: Cataract; Diabetic Retinopathy; Macular Edema Due to Diabetes Mellitus
• Interventions: Procedure: Cataract surgery

• Registration Number: NCT04660006
• Lead Sponsor: Uptown Eye Specialists

Brief Summary

The purpose of this study is to use optical coherence tomography angiography (OCT-A) to compare retinal vasculature after uncomplicated cataract surgery in patients with and without diabetic retinopathy.

Detailed Description

Patients undergoing cataract surgery who provided informed consent were enrolled in the study. There were three comparison groups: control, diabetic retinopathy (DR) and diabetic macular edema (DME) groups. Optical coherence tomography angiography (OCT-A) scans measuring retinal thickness, vessel density, perfusion density, and foveal avascular zone were obtained at baseline and postoperative week one, month one and month three.

Study Timeline

• Study Start: 2019-05-27
• Status Verified: 2020-12
• Study First Submitted: 2020-12-02
• Study First Submitted QC: 2020-12-02
• Last Update Submitted: 2020-12-02
• Study First Posted: 2020-12-09
• Last Update Posted: 2020-12-09
• Primary Completion: 2021-07
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

• All patients at Uptown Eye Specialists undergoing uneventful cataract surgery who have provided informed consent to the study.

Exclusion Criteria

• Other ocular co-morbidities such as axial length < 22.0 mm or > 25.0 mm, previous ocular surgeries, previous history of uveitis, previous ocular trauma, cornea pathologies or glaucoma, intraocular pressures over 22 mmHg
• In groups 1 and 2: previous retinal laser treatments
• OCT-A signal strength < 6
• Use of multifocal intraocular lens
• Second eye (if first eye recruited)
• In Group 1: No diabetes mellitus as past medical history

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diabetic Retinopathy (DR)	Cataract surgery	Patients with non-proliferative diabetic retinopathy with no diabetic macular edema treatment in the 6 months prior to uneventful cataract surgery.
Control	Cataract surgery	Patients undergoing uneventful cataract surgery with no retinal vascular disease.
Diabetic Macular Edema (DME)	Cataract surgery	Patients with diabetic macular edema undergoing active Anti-VEGF treatment (within the last 3 months) undergoing uneventful cataract surgery.

Primary Outcome Measures

Name	Time	Method
Change from baseline of retinal vessel density up to 3 months post-cataract surgery.	Preoperative (Baseline); Postoperative (1 Week, 1 Month, 3 Months)	Optical coherence tomography angiography (OCT-A) scans will be taken at baseline and postoperative week one, month one, and month three. This imaging modality provides measurements for retinal vessel density to be compared between groups and time.
Change from baseline of foveal avascular zone up to 3 months post-cataract surgery.	Preoperative (Baseline); Postoperative (1 Week, 1 Month, 3 Months)	Optical coherence tomography angiography (OCT-A) scans will be taken at baseline and postoperative week one, month one, and month three. This imaging modality provides measurements for foveal avascular zone (FAZ), particularly FAZ area, perimeter, and circularity index, to be compared between groups and time.
Change from baseline of retinal perfusion density up to 3 months post-cataract surgery.	Preoperative (Baseline); Postoperative (1 Week, 1 Month, 3 Months)	Optical coherence tomography angiography (OCT-A) scans will be taken at baseline and postoperative week one, month one, and month three. This imaging modality provides measurements for retinal perfusion density to be compared between groups and time.
Change from baseline of retinal thickness up to 3 months post-cataract surgery.	Preoperative (Baseline); Postoperative (1 Week, 1 Month, 3 Months)	Optical coherence tomography (OCT) scans will be taken at baseline and postoperative week one, month one, and month three. This imaging modality provides measurements of retinal thickness, particularly, central subfield and average macular cube thickness, to be compared between groups and time.

Secondary Outcome Measures

Name	Time	Method
Development of new cystoid macular edema	Preoperative (Baseline); Postoperative (1 Week, 1 Month, 3 Months)	New cases of cystoid macular edema (a potential side effect of cataract surgery) are to be recorded to determine if there are preoperative risk factors for development of cystoid macular edema post-cataract surgery.

Trial Locations

Locations (1)

Uptown Eye Speicialists; 🇨🇦 Brampton, Ontario, Canada