Endothelial Changes in Pseudoexfoliation Syndrome

NCT ID: NCT05194891

Last Updated: 2022-01-31

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

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-01

Study Completion Date

2023-03-31

Brief Summary

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this study aimed to evaluate the corneal endothelial cell changes before and after phacoemulsification in pseudoexfoliative patients relative to healthy adults.

Detailed Description

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Pseudoexfoliation syndrome (PEX) is an age related microfibrillopathy disorder characterized by the deposition of greyish white flaky exfoliative material in ocular and extraocular tissue. It commonly affects patients over 50 years old ((commonly in late 60s and 70s) with prevalence range from 0.5% to \> 30%, Although it occurs in virtually every area of the world, a considerable racial variation exists in its incidence. It is relatively rare among African Americans and Eskimos. Prevalence is high in the Sami people who are indigenous of northern Europe. There is also a high prevalence in Arabic populations. It is also well known that patients with PXF develop cataracts early in their lives. Phacoemulsification is a preferred type of cataract surgery owing to fewer complications than other types. However, it still has significant undesirable hazardous as Posterior capsular rupture, vitreous loss, Retinal detachment, Cystoid macular oedema and Posterior capsule opacification. Also, it can enhance loss of corneal endothelial cells, thickness and density that may result in corneal decompensation and subsequent corneal transplantation. In patients with PXF, small pupils and weak zonular support may enhance Phacoemulsification complications. Non-contact Specular microscope is a non-invasive method for morphological analysis of corneal density of endothelial cells, "size change" (Polymegathism), "hexagonal change" (pleomorphism). Therefore, this technology plays an important role in preoperative evaluation, surgical design and postoperative care.

Conditions

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Endothelial Cell Loss, Corneal

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Specular Microscopy

Phacoemulsification

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Patient age is above50 years.
2. Patient with nuclear cataract grade II, III.
3. Clear cornea with no evidence of endothelial disease.
4. Endothelial cell density more than 1000\\mm2.
5. Normal anterior chamber depth and dilatable pupil.
6. No active ocular disease or inflammation.
7. Pseudoexfoliative patients.

Exclusion Criteria

1. History of previous trauma, intraocular surgery or ocular surface infection in recent two weeks.
2. Presence of any corneal opacity, endothelial disease, scarring or dystrophies.
3. Pseudoexfoliative glaucoma.
4. Patients age below 50 years.
5. Endothelial cell count less than 1000\\mm2.
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Shymaa Ahmed

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shymaa Sabet, Doctor

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Central Contacts

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Shymaa Ahmed, Doctor

Role: CONTACT

Phone: +20 106 319 4646

Email: [email protected]

Hassan Shams Eldeen, Assis. Prof

Role: CONTACT

Phone: +20 114 409 0050

Email: [email protected]

Other Identifiers

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Endothelial Changes in PEX

Identifier Type: -

Identifier Source: org_study_id