Corneal Biomechanics and Surgically Induced Astigmatism in Pseudoexfoliation Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: phacoemulsification cataract surgery.
- Who it may be relevant to
- Registry conditions: Pseudoexfoliation Syndrome, Cataract, Astigmatism. Basic parameters: 50 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Croatia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Influence of Corneal Biomechanics on Surgically Induced Astigmatism After Cataract Surgery in Patients With Pseudoexfoliation Syndrome
Overview
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.
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.
Interventions
- Procedure phacoemulsification cataract surgery
Standard phacoemulsification cataract surgery with intraocular lens implantation performed according to routine clinical practice.
Primary outcome measures
- Correlation between corneal biomechanical properties and surgically induced astigmatism [Time frame: Preoperative, postoperative day 1, postoperative day 7, and postoperative day 30.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Croatia · 1 center
- Eye Clinic Medic Jukic — Split
Identifiers
NCT: NCT07722247 · AST-PEXCAT-2026