Endothelial Changes in Pseudoexfoliation Syndrome

• Conditions: Endothelial Cell Loss, Corneal

• Registration Number: NCT05194891
• Lead Sponsor: Assiut University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Status Verified: 2022-01
• Study First Submitted: 2022-01-04
• Study First Submitted QC: 2022-01-04
• Last Update Submitted: 2022-01-15
• Study First Posted: 2022-01-18
• Last Update Posted: 2022-01-31
• Study Start: 2022-02-01
• Primary Completion: 2023-02
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Study of corneal endothelial changes in pseudoexfoliation syndrome	Baseline	Comparison of corneal endothelial changes after phacoemulsification in patients with pseudoexfoliation and patient with cataract only