Detecting the Influence of Cataract Surgery on the Development of Diabetic Retinopathy in Patients With Diabetes Mellitus Type 2 With and Without Diabetic Retinopathy Using OCT Angiography

• Conditions: Diabetic Retinopathy
• Interventions: Device: Phacoemulsification

• Registration Number: NCT03571139
• Lead Sponsor: Cairo University

Brief Summary

Detecting the influence of cataract surgery on the development of diabetic retinopathy in patients with diabetes mellitus type 2 with and without diabetic retinopathy using OCT angiography.

Detailed Description

Patients with diabetes mellitus type 2 with and without without diabetic retinopathy (on biomicroscopy examination) who need cataract surgery, will undergo OCT angiography examination prior to their cataract surgery. Average vessel density (%) in superficial capillary plexus, deep capillary plexus and choriocapillaris, parafoveal vessel density (%) in the superficial and deep plexuses, FAZ area (mm2) in the superficial capillary plexus, FAZ circularity, retinal thickness, microaneurysms and capillary non-perfusion will be taken into analysis.

Patients will be examined on the first day after the cataract surgery with phacoemulsification and in the bag posterior chamber lens implantation.

All patients will undergo OCT angiography examination four weeks after their cataract surgery.

Study Timeline

• Status Verified: 2018-06
• Study Start: 2018-06-01
• Study First Submitted: 2018-06-15
• Study First Submitted QC: 2018-06-26
• Study First Posted: 2018-06-27
• Last Update Submitted: 2018-06-27
• Last Update Posted: 2018-06-28
• Primary Completion: 2018-12
• Study Completion: 2019-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients with diabetes mellitus type 2 with and without diabetic retinopathy who needs cataract surgery.
• Patients who need cataract surgery without any intravitreal injections.
• Absence of any ocular disease other than diabetes mellitus.
• Cataract density allowing good visualization of the fundus by OCT angiography.
• Patients with uneventful cataract surgery with phacoemulsification.

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Exclusion Criteria

• Patients who fail to comply with the follow-up schedule.
• Very dense cataract not allowing good visualization of the fundus by OCT angiography.
• Patients with complicated cataract surgery with phacoemulsification.
• Patients who need cataract surgery with any intravitreal injection.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diabetics type 2 with and without diabetic retinopathy	Phacoemulsification	Patients with diabetes mellitus type 2 with and without diabetic retinopathy who needs cataract surgery by phacoemulsification. All patients will undergo OCT angiography examination prior to their cataract surgery and 4 weeks after the cataract surgery.

Primary Outcome Measures

Name	Time	Method
Detecting changes in the retinal vascular plexuses and choriocapillaris after cataract surgery in type 2 diabetes mellitus patients with and without diabetic retinopathy using OCT angiography.	1 month	Changes in the retinal vascular plexus, superficial and deep vessel density, foveal avascular zone area, circularity and any developing microaneurysms and areas of retinal ischemia will be measured to see the influence of cataract surgery on diabetic retinopathy.

Trial Locations

Locations (1)

German Eye Center; 🇯🇴 Amman, Jordan