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NCT07719101

Overview

NCT ID: NCT07719101
Lead Sponsor: Kata CulinaOTHER
Official Title: The Influence of Cataract Surgery on Corneal Biomechanical Properties in Patients With Pseudoexfoliation Syndrome: A Prospective Observational Cohort Study
Brief Summary: Pseudoexfoliation syndrome is associated with alterations in the biomechanical properties of the cornea. This prospective observational cohort study aims to evaluate changes in corneal biomechanical properties after standard phacoemulsification cataract surgery in patients with pseudoexfoliation syndrome compared with patients without pseudoexfoliation syndrome. Corneal hysteresis (CH) and corneal resistance factor (CRF) will be measured using the Ocular Response Analyzer before surgery and at postoperative day 1, day 7, and day 30. The study will enroll patients undergoing routine cataract surgery to compare postoperative changes in CH and CRF between the pseudoexfoliation and control groups.
Conditions: Pseudoexfoliation Syndrome

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 23, 2026Actual
Start Date: Jul 20, 2026Estimated
Primary Completion Date: Oct 2026Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

adults aged 50 years and older

presence of age-related cataract requiring phacoemulsification cataract surgery

presence of pseudoexfoliation syndrome (PEX group) or absence of pseudoexfoliation syndrome (control group)

ability and willingness to provide written consent

Exclusion Criteria:

previous ocular surgery,

corneal disease,

glaucoma or ocular hypertension,

dry eye disease (Schirmer test <10 mm, tear break-up time <5 seconds or positive fluorescein staining),

high refractive error (myopia > -6.00 D or hyperopia > +5.00 D),

unilateral pseudoexfoliation when the eye scheduled for surgery showed Adults no signs of PEX,

intraoperative or postoperative complications,

any ocular disease that could influence corneal biomechanics

Study Plan

Study Type: Observational
Phase: No data available
Enrollment: 70Estimated
Primary Purpose: No data available
Allocation: No data available
Interventional Model: No data available
Masking: No data available

Contacts and Locations

Central Contacts: Kata Culina, MD, PhDContact
kculina@yahoo.com+38598615556

Similar Studies

Participant Group/Arms

Pseudoexfoliation syndrome

Patients with clinically diagnosed pseudoexfoliation syndrome undergoing standard phacoemulsification cataract surgery. Corneal hysteresis (CH) and corneal resistance factor (CRF) will be measured preoperatively and on postoperative day 1, day 7 and day 30.

Control

Patients without pseudoexfoliation syndrome undergoing standard phacoemulsification cataract surgery. Corneal hysteresis (CH) and corneal resistance factor (CRF) will be measured preoperatively and on postoperative day 1, day 7 and day 30.