Pseudoexfoliation SyndromeNCT07722247
Corneal Biomechanics and Surgically Induced Astigmatism in Pseudoexfoliation Syndrome
An observational study of Pseudoexfoliation Syndrome and Cataract, run by Kata Culina at 1 site in Croatia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Pseudoexfoliation Syndrome, Cataract, Astigmatism
- What is being tested?
- phacoemulsification cataract surgery
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteCroatia
- Study dates
- 20 Jul 2026to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Croatia1 site, 1 recruiting
- Recruiting
Eye Clinic Medic Jukic
Split, Splitsko-dalmatinska County, 21000
Kata Culina, MD, PhD, +38598615556, kculina@yahoo.com
Culina, kculina@yahoo.com
About this study
Official title: Influence of Corneal Biomechanics on Surgically Induced Astigmatism After Cataract Surgery in Patients With 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.
Read the 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.
- Conditions
- Pseudoexfoliation Syndrome, Cataract, Astigmatism
- Being tested
- phacoemulsification cataract surgery
- Keywords
- corneal biomechanics, corneal hysteresis, corneal resistence factor, cataract surgery, pseudoexfoliation syndrome, surgically induced astigmatism
- Medical subject headings
- Exfoliation Syndrome, Cataract, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phacoemulsification cataract surgeryProcedure or surgery
Standard phacoemulsification cataract surgery with intraocular lens implantation performed according to routine clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Pseudoexfoliation syndrome | Patients with pseudoexfoliation syndrome undergoing standard phacoemulsification cataract surgery Receives: Procedure: phacoemulsification cataract surgery | |
| Control group | Patients without pseudoexfoliation syndrome undergoing standard phacoemulsification cataract surgery Receives: Procedure: phacoemulsification cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Preoperative, postoperative day 1, postoperative day 7, and postoperative day 30.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start20 Jul 2026
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pseudoexfoliation SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kata Culina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kata Culina, Eye Clinic Medic Zuljan Jukic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07722247
- Sponsor's protocol ID
- AST-PEXCAT-2026
- Status last verified
- Aug 2026
- First submitted
- 20 Jul 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Corneal Biomechanics on Surgically Induced Astigmatism After Cataract Surgery in Patients With Pseudoexfoliation Syndrome
- ClinicalTrials.gov ID
- NCT07722247
- Acronym / sponsor ID
- AST-PEXCAT-2026
- Conditions
- Pseudoexfoliation Syndrome, Cataract, Astigmatism
- Keywords
- corneal biomechanics, corneal hysteresis, corneal resistence factor, cataract surgery, pseudoexfoliation syndrome, surgically induced astigmatism
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Kata CulinaUniversity, hospital or other
- Study start
- 20 Jul 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 23 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pseudoexfoliation syndrome | – | Procedure: phacoemulsification cataract surgeryPatients with pseudoexfoliation syndrome undergoing standard phacoemulsification cataract surgery |
| Control group | – | Procedure: phacoemulsification cataract surgeryPatients without pseudoexfoliation syndrome undergoing standard phacoemulsification cataract surgery |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| phacoemulsification cataract surgeryStandard phacoemulsification cataract surgery with intraocular lens implantation performed according to routine clinical practice. | Procedure or surgery | Control group, Pseudoexfoliation syndrome |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pseudoexfoliation Syndrome and Cataract, run by Kata Culina at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kata Culina, MD, PhD (+38598615556, kculina@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between corneal biomechanical properties and surgically induced astigmatism (time frame: Preoperative, postoperative day 1, postoperative day 7, and postoperative day 30.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.