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

June 27, 2018 updated by: Abeer Tawfik Al Hanaineh, Cairo University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Jordan
      • Amman, Jordan
        • Recruiting
        • German Eye Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Cataract surgery and in the bag posterior chamber lens implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Abeer T Al Hanaineh, MSc, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

January 1, 2019

Study Registration Dates

First Submitted

June 15, 2018

First Submitted That Met QC Criteria

June 26, 2018

First Posted (Actual)

June 27, 2018

Study Record Updates

Last Update Posted (Actual)

June 28, 2018

Last Update Submitted That Met QC Criteria

June 27, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Abeer T Al Hanaineh

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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