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

Diabetic Retinopathy Clinical Trial

Official title:

OCT Angiography Changes in Patients With Diabetes Mellitus Type 2 With and Without Diabetic Retinopathy Undergoing Phacoemulsification

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03571139
• Other study ID #: Abeer T Al Hanaineh
• Status: Recruiting
• Start date: June 1, 2018
• Est. completion date: January 2019

Study information

• Verified date: June 2018
• Source: Cairo University
• Contact: Abeer T Al Hanaineh, MSc
• Phone: 0096279184460
• Email: abeer_alhanaineh[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetic Retinopathy
• Retinal Diseases

Intervention

Device:
• Phacoemulsification
Cataract surgery and in the bag posterior chamber lens implantation

Locations

Country	Name	City	State
Jordan	German Eye Center	Amman

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	1 month