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NCT Number: NCT07722247

Corneal Biomechanics and Surgically Induced Astigmatism in 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.

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Key information

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Phacoemulsification Cataract Surgery

Procedure

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

Primary outcomes

  1. 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.

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

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 23, 2026
Registry last updated
Jul 24, 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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