Evaluation of Corneal Endothelial Changes After Uneventful Phacoemulsification in Diabetic and Non-diabetic Patients in Relation to the Level of Glcosylated Hemoglobin Level

June 21, 2022 updated by: Marwa Ahmed
Evaluation of corneal endothelial changes after uneventful phacoemulsification in diabetic and non-diabetic patients using specular biomicroscopy in relation to the level of glcosylated hemoglobin level

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

86 patients will be divided into two equal groups of diabetic and non-diabetic patients will undergo phacoemulsification of cataract will be evaluated thier endocelium before surgery and 3 weeks after surgery to detect the effect of level of glcosylated hemoglobin on the endothelial changes after uneventful phacoemulsification

Study Type

Interventional

Enrollment (Anticipated)

68

Phase

  • Not Applicable

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 Contact Backup

Study Locations

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

50 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diabetics and non-diabetic patients undergo cataract surgery
  • Age between 50-60 years old
  • Corrected distance visual acuity<0.4
  • Gender: both genders.

Exclusion Criteria:

  • Chronic Ocular diseases (glaucoma,uveitis, amblyopia, strabismus,keratoconus, corneal opacity).
  • corneal dystrophy History of previous keratitis or viral corneal infection. Corneal dystrophy Ocular trauma. Previous ocular surgery. Complicated cataract surgery

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

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Diabetic patient
Patient with diabetes will undergo cataract surgery
Device: Specular biomicroscopy
Specular microscopy will be done before and 3 weeks after cataract surgery
Active Comparator: Non diabetic patients
Healthy non diabetic patients will undergo cataract surgery
Device: Specular biomicroscopy
Specular microscopy will be done before and 3 weeks after cataract surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Defferentiate patients into diabetic and non-diabetic patients according to the endothelial changes after uneventful phacoemulsification
Time Frame: 6 monthes
Detect effect of glycosylated hemoglobin level after uneventful phacoemulsification in diabetic and non-diabetic patients
6 monthes

Collaborators and Investigators

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

Sponsor

Marwa Ahmed

Investigators

  • Principal Investigator: Mohamed A Hosny, MD, 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)

May 20, 2022

Primary Completion (Anticipated)

November 17, 2022

Study Completion (Anticipated)

November 17, 2022

Study Registration Dates

First Submitted

June 4, 2022

First Submitted That Met QC Criteria

June 21, 2022

First Posted (Actual)

June 22, 2022

Study Record Updates

Last Update Posted (Actual)

June 22, 2022

Last Update Submitted That Met QC Criteria

June 21, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • KasrAlAiny

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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