An observational study in Pseudoexfoliation Syndrome, Cataract and Astigmatism, sponsored by Kata Culina. Recruiting at 1 site in Croatia. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Kata Culina · Observational
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.
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.
72 studies on the registry are indexed under Exfoliation Syndrome; 20 are open to participants now.
This study's planned enrollment of 70 is close to the median of 76 across 38 observational studies indexed under Exfoliation Syndrome.
Browse Exfoliation Syndrome studies →Kata Culina is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with pseudoexfoliation syndrome undergoing standard phacoemulsification cataract surgery
Procedure: phacoemulsification cataract surgery
Patients without pseudoexfoliation syndrome undergoing standard phacoemulsification cataract surgery
Procedure: phacoemulsification cataract surgery
Standard phacoemulsification cataract surgery with intraocular lens implantation performed according to routine clinical practice.
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.
Time frame: Preoperative, postoperative day 1, postoperative day 7, and postoperative day 30.
Plan to share: No — Individual participant data will not be shared.
No publications or documents are linked to this record.
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