Influence of Cataract Surgery on Corneal Biomechanical Properties in Patients With Pseudoexfoliation Syndrome

July 17, 2026 updated by: Kata Culina

The Influence of Cataract Surgery on Corneal Biomechanical Properties in Patients With Pseudoexfoliation Syndrome: A Prospective Observational Cohort Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Croatia
    • Splitsko-dalmatinska County
      • Split, Splitsko-dalmatinska County, Croatia, 21000
        • Eye Clinic Medic Jukic
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kata Culina, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults with age-related cataract scheduled for routine phacoemulsification cataract surgery. Participants will be enrolled into either the pseudoexfoliation syndrome group or the control group and followed for 30 days after surgery

Description

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in corneal hysteresis (CH)
Time Frame: Baseline, postoperative day 1, day 7 and day 30
Change in corneal hysteresis measured by Ocular response analyzer before cataract surgery and at postoperative day 1, day 7 and day 30. Changes will be compared between patients with pseudoexfoliation syndrome and controls.
Baseline, postoperative day 1, day 7 and day 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in corneal resistance factor (CRF)
Time Frame: Baseline, postoperative day 1, day 7 and day 30
Change in corneal resistance factor measured by Ocular response analyzer before cataract surgery and at postoperative day 1, day 7 and day 30. Changes will be compared between patients with pseudoexfoliation syndrome and controls.
Baseline, postoperative day 1, day 7 and day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kata Culina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 20, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

July 17, 2026

First Submitted That Met QC Criteria

July 17, 2026

First Posted (Actual)

July 22, 2026

Study Record Updates

Last Update Posted (Actual)

July 22, 2026

Last Update Submitted That Met QC Criteria

July 17, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEX-CHCRF-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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