Endothelial Changes in Pseudoexfoliation Syndrome

Endothelial Cell Loss, Corneal Clinical Trial

— PEX  

Official title:

Specular Microscopic Changes of Corneal Endothelial Cells After Phacoemulsification in Patients With Pseudo Exfoliation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05194891
• Other study ID #: Endothelial Changes in PEX
• Status: Not yet recruiting
• Start date: February 1, 2022
• Est. completion date: March 2023

Study information

• Verified date: January 2022
• Source: Assiut University
• Contact: Shymaa Ahmed, Doctor
• Phone: +20 106 319 4646
• Email: shymaa.sabet[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: March 2023
• Est. primary completion date: February 2023
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Corneal Endothelial Cell Loss
• Endothelial Cell Loss, Corneal

Intervention

Diagnostic Test:
• Specular Microscopy
Phacoemulsification

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study of corneal endothelial changes in pseudoexfoliation syndrome	Comparison of corneal endothelial changes after phacoemulsification in patients with pseudoexfoliation and patient with cataract only	Baseline