Corneal Biomechanics and Surgically Induced Astigmatism in Pseudoexfoliation Syndrome

NCT07722247 | Not Yet Recruiting

• 1 other identifier: AST-PEXCAT-2026
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Astigmatism; Pseudoexfoliation Syndrome; Cataract

Keywords

corneal biomechanics; corneal hysteresis; corneal resistence factor; cataract surgery; pseudoexfoliation syndrome; surgically induced astigmatism

Outcome Measures

Primary Outcomes (1)

• Correlation between corneal biomechanical properties and surgically induced astigmatism

  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.

Study Arms (2)

Pseudoexfoliation syndrome

Patients with pseudoexfoliation syndrome undergoing standard phacoemulsification cataract surgery

Procedure: phacoemulsification cataract surgery

Control group

Patients without pseudoexfoliation syndrome undergoing standard phacoemulsification cataract surgery

Procedure: phacoemulsification cataract surgery

Interventions

phacoemulsification cataract surgery PROCEDURE

Standard phacoemulsification cataract surgery with intraocular lens implantation performed according to routine clinical practice.

Control group; Pseudoexfoliation syndrome

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kata Culina: lead

Study Sites (1)

Eye Clinic Medic Jukic

Split, Splitsko-dalmatinska County, 21000, Croatia

Location

MeSH Terms

Conditions

Exfoliation Syndrome; Cataract; Astigmatism

Condition Hierarchy (Ancestors)

Iris Diseases; Uveal Diseases; Eye Diseases; Lens Diseases; Refractive Errors

Central Study Contacts

Kata Culina, MD, PhD

CONTACT

+38598615556; kculina@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator, Ophthalmologist

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 23, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)