Diabetic Retinopathy and OCT-A Changes Post-cataract Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Optical Coherence Tomography Angiography Changes Post-cataract Surgery in Patients With and Without Diabetic Retinopathy

Conditions
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Cataract, Diabetic Retinopathy, Macular Edema Due to Diabetes Mellitus

Intervention / Treatment
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* Procedure: Cataract surgery


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control<br>Patients undergoing uneventful cataract surgery with no retinal vascular disease. | Procedure: Cataract surgery<br>* Patients undergoing uneventful cataract surgery were recruited to this study if they met the inclusion criteria of the three groups. Postoperative retinal vasculature measures, as recorded by the optical coherence tomography angiography imaging technique, were compared to baseline measures.<br>|
| Diabetic Retinopathy (DR)<br>Patients with non-proliferative diabetic retinopathy with no diabetic macular edema treatment in the 6 months prior to uneventful cataract surgery. | Procedure: Cataract surgery<br>* Patients undergoing uneventful cataract surgery were recruited to this study if they met the inclusion criteria of the three groups. Postoperative retinal vasculature measures, as recorded by the optical coherence tomography angiography imaging technique, were compared to baseline measures.<br>|
| Diabetic Macular Edema (DME)<br>Patients with diabetic macular edema undergoing active Anti-VEGF treatment (within the last 3 months) undergoing uneventful cataract surgery. | Procedure: Cataract surgery<br>* Patients undergoing uneventful cataract surgery were recruited to this study if they met the inclusion criteria of the three groups. Postoperative retinal vasculature measures, as recorded by the optical coherence tomography angiography imaging technique, were compared to baseline measures.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of retinal vessel density up to 3 months post-cataract surgery. | 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. | Preoperative (Baseline); Postoperative (1 Week, 1 Month, 3 Months) | 
| Change from baseline of retinal perfusion density up to 3 months post-cataract surgery. | 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. | Preoperative (Baseline); Postoperative (1 Week, 1 Month, 3 Months) | 
| Change from baseline of foveal avascular zone up to 3 months post-cataract surgery. | 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. | Preoperative (Baseline); Postoperative (1 Week, 1 Month, 3 Months) | 
| Change from baseline of retinal thickness up to 3 months post-cataract surgery. | 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. | Preoperative (Baseline); Postoperative (1 Week, 1 Month, 3 Months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of new cystoid macular edema | 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. | Preoperative (Baseline); Postoperative (1 Week, 1 Month, 3 Months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Optical Coherence Tomography Angiography