Corneal Biomechanics and Surgically Induced Astigmatism in Pseudoexfoliation Syndrome
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-85
SponsorKata Culina
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
phacoemulsification cataract surgery
Procedure/SurgeryStandard phacoemulsification cataract surgery with intraocular lens implantation performed according to routine clinical practice.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Pseudoexfoliation syndrome1 intervention
Group B: Control group1 intervention
Trial outcomes
Primary outcomes
1
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.Sponsors and contacts
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Kata Culina
Lead sponsor
Eye Clinic Medic Zuljan Jukic
Sponsor institution
Source ClinicalTrials.gov