Corneal Biomechanics and Surgically Induced Astigmatism in Pseudoexfoliation Syndrome

July 23, 2026 updated by: Kata Culina

Influence of Corneal Biomechanics on Surgically Induced Astigmatism After Cataract Surgery in Patients With Pseudoexfoliation Syndrome

This prospective study aims to evaluate the influence of corneal biomechanical properties on surgically induced astigmatism following standard phacoemulsification cataract surgery in patients with pseudoexfoliation syndrome compared with patients without pseudoexfoliation. Corneal hysteresis (CH), corneal resistance factor (CRF) and corneal astigmatism will be measured before surgery and at postoperative follow-up visits. The relationship between changes in corneal biomechanics and surgically induced astigmatism will be analyzed.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Pseudoexfoliation syndrome is associated with structural alterations of the anterior segment and may affect the biomechanical behavior of the cornea. Corneal hysteresis (CH) and corneal resistance factor (CRF), measured using the Ocular Response Analyzer, are indicators of corneal biomechanical properties and may influence the corneal response to cataract surgery and magnitude of surgically induced astigmatism.

This prospective, single-center observational study will include approximately 70 patients undergoing routine phacoemulsification cataract surgery. Participants will be allocated into two groups according to the presence or absence of pseudoexfoliation syndrome.

CH, CRF and corneal astigmatism will be measured preoperatively and postoperatively at scheduled follow-up visits at postoperative day 1, 7 and 30. Surgically induced astigmatism will be calculated from keratometric measurements.

The primary objective of the study is to determine whether correlations exist between corneal biomechanical properties (CH and CRF) and surgically induced astigmatism in patients with pseudoexfoliation syndrome and to compare these correlations with those observed in patients without pseudoexfoliation syndrome.

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

The study population will consist of adult patients with age-related cataract scheduled for routine phacoemulsification cataract surgery at Eye clinic Medic Jukic. Participants will include patients with pseudoexfoliation syndrome and an a control group without pseudoexfoliation syndrome of similar age range. Consecutive eligible patients who meet the inclusion criteria and provide written informed consent will be enrolled.

Description

Inclusion Criteria:

  • Adults aged 50-85 years
  • Age-related cataract scheduled for standard phacoemulsification cataract surgery with intraocular lens implantation
  • Presence of pseudoexfoliation syndrome (PEX group) or absence of pseudoexfoliation syndrome (control group)
  • Ability to provide written informed consent
  • Willingness to attend all scheduled postoperative follow-up visits

Exclusion Criteria:

  • Previous ocular surgery in the study eye
  • Corneal diseases or abnormalities that may affect corneal biomechanical measurements or keratometry
  • Glaucoma and ocular hypertension
  • Ocular trauma or active ocular inflammation

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
Intervention / Treatment
Pseudoexfoliation syndrome
Patients with pseudoexfoliation syndrome undergoing standard phacoemulsification cataract surgery
Procedure: phacoemulsification cataract surgery
Standard phacoemulsification cataract surgery with intraocular lens implantation performed according to routine clinical practice.
Control group
Patients without pseudoexfoliation syndrome undergoing standard phacoemulsification cataract surgery
Procedure: phacoemulsification cataract surgery
Standard phacoemulsification cataract surgery with intraocular lens implantation performed according to routine clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between corneal biomechanical properties and surgically induced astigmatism
Time Frame: Preoperative, postoperative day 1, postoperative day 7, and postoperative day 30.
To evaluate the correlation between corneal hysteresis (CH), corneal resistance factor (CRF), and surgically induced astigmatism (SIA) after phacoemulsification cataract surgery in patients with pseudoexfoliation syndrome and compare the findings with a control group.
Preoperative, postoperative day 1, postoperative day 7, and postoperative 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 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

July 20, 2026

First Submitted That Met QC Criteria

July 20, 2026

First Posted (Actual)

July 23, 2026

Study Record Updates

Last Update Posted (Actual)

July 24, 2026

Last Update Submitted That Met QC Criteria

July 23, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AST-PEXCAT-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared.

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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