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

NCT ID: NCT05426590

Last Updated: 2022-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-20

Study Completion Date

2022-11-17

Brief Summary

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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

Detailed Description

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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

Conditions

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Corneal Endothelial Changes After Phacoemulsification

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Diabetic patient

Patient with diabetes will undergo cataract surgery

Group Type ACTIVE_COMPARATOR

Specular biomicroscopy

Intervention Type DEVICE

Specular microscopy will be done before and 3 weeks after cataract surgery

Non diabetic patients

Healthy non diabetic patients will undergo cataract surgery

Group Type ACTIVE_COMPARATOR

Specular biomicroscopy

Intervention Type DEVICE

Specular microscopy will be done before and 3 weeks after cataract surgery

Interventions

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Specular biomicroscopy

Specular microscopy will be done before and 3 weeks after cataract surgery

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Marwa Ahmed

OTHER

Sponsor Role lead

Responsible Party

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Marwa Ahmed

Clinical professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mohamed A Hosny, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Cairo University

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Marwa A Abdelaal

Role: CONTACT

01129875785

Mohamed A Hosney

Role: CONTACT

01000007676

Facility Contacts

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Mohamed A Hosny

Role: primary

01000007676

Other Identifiers

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KasrAlAiny

Identifier Type: -

Identifier Source: org_study_id

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