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

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07719101

Enrollment

Registered

2026-07-22

Start date

2026-07-20

Completion date

2026-10-01

Last updated

2026-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract, Pseudoexfoliation Syndrome

Keywords

corneal biomechanics, corneal hysteresis, corneal resistance factor, pseudoexfoliation syndrome, cataract surgery

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change in corneal hysteresis (CH)	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.

Secondary

Measure	Time frame	Description
Change in corneal resistance factor (CRF)	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.

Countries

Croatia

Contacts

CONTACTKata Culina, MD, PhD

kculina@yahoo.com+38598615556

Outcome results