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NCT Number: NCT07719101

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

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.

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Key information

Conditions

Pseudoexfoliation Syndrome Cataract Exfoliation Syndrome Eye Diseases Iris Diseases Lens Diseases Uveal Diseases

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kata Culina, MD, PhD

CONTACT

[email protected]

+38598615556

Sponsors and collaborators

Lead sponsor

Kata Culina

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 22, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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