Endothelial Changes in Pseudoexfoliation Syndrome

NCT05194891 — Unknown, 100 participants, Assiut University

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

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

RegistryNCT05194891, acronym PEX
StatusUnknown
Study typeObservational
Enrollment100 (Estimated)
SponsorAssiut University (Other)
ConditionsEndothelial Cell Loss, Corneal
InterventionsSpecular Microscopy (Diagnostic test)
Datesstart 2022-02-01 (estimated), primary completion 2023-02-01 (estimated), completion 2023-03-01 (estimated), first posted 2022-01-18, last updated 2022-01-31

Related Papers Related Patents Related Grants Related Experts
All trials for Endothelial Cell Loss, Corneal All trials of Specular Microscopy

-Summary

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

Expand all sections  ·  Collapse all

+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.

+Arms and interventions

  • Specular Microscopy (Diagnostic test): Phacoemulsification

+Outcome measures

Primary outcomes

  • 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

+Eligibility

Sex: All, ages: 50 Years to 75 Years

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.

+Investigators