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

Sponsor
Marwa Ahmed (Other)
Overall Status
Recruiting
CT.gov ID
NCT05426590
Collaborator
(none)
68
Enrollment
1
Location
2
Arms
5.9
Anticipated Duration (Months)
11.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Specular biomicroscopy
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
68 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Evaluation of Corneal Endothelial Changes After Uneventful Phacoemulsification in Diabetic and Non-diabetic Patients in Relation to the Level of Glcosylated Hemoglobin Level
Actual Study Start Date :
May 20, 2022
Anticipated Primary Completion Date :
Nov 17, 2022
Anticipated Study Completion Date :
Nov 17, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Defferentiate patients into diabetic and non-diabetic patients according to the endothelial changes after uneventful phacoemulsification [6 monthes]

    Detect effect of glycosylated hemoglobin level after uneventful phacoemulsification in diabetic and non-diabetic patients

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cairo University Cairo Egypt

Sponsors and Collaborators

  • Marwa Ahmed

Investigators

  • Principal Investigator: Mohamed A Hosny, MD, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Marwa Ahmed, Clinical professor, Cairo University
ClinicalTrials.gov Identifier:
NCT05426590
Other Study ID Numbers:
  • KasrAlAiny
First Posted:
Jun 22, 2022
Last Update Posted:
Jun 22, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 22, 2022