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

NCT03571139 | Unknown FDA Device

• 1 other identifier: Abeer T Al Hanaineh
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Retinopathy

Keywords

OCT angiography; Diabetic retinopathy; Cataract surgery

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Diabetics type 2 with and without diabetic retinopathy

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.

Device: Phacoemulsification

Interventions

Phacoemulsification DEVICE

Cataract surgery and in the bag posterior chamber lens implantation

Diabetics type 2 with and without diabetic retinopathy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with diabetes mellitus type 2 with and without diabetic retinopathy (on biomicroscopy examination) who need cataract surgery.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

German Eye Center

Amman, Jordan

RECRUITING

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

Phacoemulsification

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Cataract Extraction; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Ultrasonic Surgical Procedures

Study Officials

• Abeer T Al Hanaineh, MSc

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abeer T Al Hanaineh, MSc

CONTACT

0096279184460; abeer_alhanaineh@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: June 15, 2018
• First Posted: June 27, 2018
• Study Start: June 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: January 1, 2019
• Last Updated: June 28, 2018

Record last verified: 2018-06

Locations

JO (1)