Pseudoexfoliation SyndromeNCT07719101
Influence of Cataract Surgery on Corneal Biomechanical Properties in Patients With Pseudoexfoliation Syndrome
An observational study of Pseudoexfoliation Syndrome and Cataract, run by Kata Culina at 1 site in Croatia.
Trial summary
Pseudoexfoliation syndrome is associated with alterations in the biomechanical properties of the cornea. This prospective observational cohort study aims to evaluate changes in corneal biomechanical properties after standard phacoemulsification cataract surgery in patients with pseudoexfoliation syndrome compared with… Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Pseudoexfoliation Syndrome, Cataract
- 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: Adults with age-related cataract scheduled for routine phacoemulsification cataract surgery. Participants will be enrolled into either the pseudoexfoliation syndrome group or the control group and followed for 30 days after surgery
Who may be able to join
- adults aged 50 years and older
- presence of age-related cataract requiring phacoemulsification cataract surgery
- presence of pseudoexfoliation syndrome (PEX group) or absence of pseudoexfoliation syndrome (control group)
- ability and willingness to provide written consent
Who cannot join
- previous ocular surgery,
- corneal disease,
- glaucoma or ocular hypertension,
- dry eye disease (Schirmer test <10 mm, tear break-up time <5 seconds or positive fluorescein staining),
- high refractive error (myopia > -6.00 D or hyperopia > +5.00 D),
- unilateral pseudoexfoliation when the eye scheduled for surgery showed Adults no signs of PEX,
- intraoperative or postoperative complications,
- any ocular disease that could influence corneal biomechanics
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
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: The Influence of Cataract Surgery on Corneal Biomechanical Properties in Patients With Pseudoexfoliation Syndrome: A Prospective Observational Cohort Study
Pseudoexfoliation syndrome is associated with alterations in the biomechanical properties of the cornea. This prospective observational cohort study aims to evaluate changes in corneal biomechanical properties after standard phacoemulsification cataract surgery in patients with pseudoexfoliation syndrome compared with patients without pseudoexfoliation syndrome. Corneal hysteresis (CH) and corneal resistance factor (CRF) will be measured using the Ocular Response Analyzer before surgery and at postoperative day 1, day 7, and day 30. The study will enroll patients undergoing routine cataract surgery to compare postoperative changes in CH and CRF between the pseudoexfoliation and control groups.
- Conditions
- Pseudoexfoliation Syndrome, Cataract
- Keywords
- corneal biomechanics, corneal hysteresis, corneal resistance factor, pseudoexfoliation syndrome, cataract surgery
- Medical subject headings
- Exfoliation Syndrome, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pseudoexfoliation syndrome | Patients with clinically diagnosed pseudoexfoliation syndrome undergoing standard phacoemulsification cataract surgery. Corneal hysteresis (CH) and corneal resistance factor (CRF) will be measured preoperatively and on postoperative day 1, day 7 and day 30. | |
| Control | Patients without pseudoexfoliation syndrome undergoing standard phacoemulsification cataract surgery. Corneal hysteresis (CH) and corneal resistance factor (CRF) will be measured preoperatively and on postoperative day 1, day 7 and day 30. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in corneal hysteresis (CH)
Change in corneal hysteresis measured by Ocular response analyzer before cataract surgery and at postoperative day 1, day 7 and day 30. Changes will be compared between patients with pseudoexfoliation syndrome and controls.
Measured: Baseline, postoperative day 1, day 7 and day 30
Secondary outcomes (1)
Change in corneal resistance factor (CRF)
Change in corneal resistance factor measured by Ocular response analyzer before cataract surgery and at postoperative day 1, day 7 and day 30. Changes will be compared between patients with pseudoexfoliation syndrome and controls.
Measured: Baseline, postoperative day 1, day 7 and day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start20 Jul 2026 (estimated)
- 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
- NCT07719101
- Sponsor's protocol ID
- PEX-CHCRF-2026
- Status last verified
- Jul 2026
- First submitted
- 17 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Cataract Surgery on Corneal Biomechanical Properties in Patients With Pseudoexfoliation Syndrome: A Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07719101
- Acronym / sponsor ID
- PEX-CHCRF-2026
- Conditions
- Pseudoexfoliation Syndrome, Cataract
- Keywords
- corneal biomechanics, corneal hysteresis, corneal resistance factor, pseudoexfoliation syndrome, cataract surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Kata CulinaUniversity, hospital or other
- Study start
- 20 Jul 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 22 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.
Pseudoexfoliation syndrome is associated with alterations in the biomechanical properties of the cornea. This prospective observational cohort study aims to evaluate changes in corneal biomechanical properties after standard phacoemulsification cataract surgery in patients with pseudoexfoliation syndrome compared with patients without pseudoexfoliation syndrome. Corneal hysteresis (CH) and corneal resistance factor (CRF) will be measured using the Ocular Response Analyzer before surgery and at postoperative day 1, day 7, and day 30. The study will enroll patients undergoing routine cataract surgery to compare postoperative changes in CH and CRF between the pseudoexfoliation and control groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pseudoexfoliation syndrome | – | –Patients with clinically diagnosed pseudoexfoliation syndrome undergoing standard phacoemulsification cataract surgery. Corneal hysteresis (CH) and corneal resistance factor (CRF) will be measured preoperatively and on postoperative day 1, day 7 and day 30. |
| Control | – | –Patients without pseudoexfoliation syndrome undergoing standard phacoemulsification cataract surgery. Corneal hysteresis (CH) and corneal resistance factor (CRF) will be measured preoperatively and on postoperative day 1, day 7 and day 30. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with age-related cataract scheduled for routine phacoemulsification cataract surgery. Participants will be enrolled into either the pseudoexfoliation syndrome group or the control group and followed for 30 days after surgery
Key inclusion criteria (4 listed)
- adults aged 50 years and older
- presence of age-related cataract requiring phacoemulsification cataract surgery
- presence of pseudoexfoliation syndrome (PEX group) or absence of pseudoexfoliation syndrome (control group)
- ability and willingness to provide written consent
Key exclusion criteria (8 listed)
- previous ocular surgery,
- corneal disease,
- glaucoma or ocular hypertension,
- dry eye disease (Schirmer test <10 mm, tear break-up time <5 seconds or positive fluorescein staining),
- high refractive error (myopia > -6.00 D or hyperopia > +5.00 D),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in corneal hysteresis (CH)
Time frame: Baseline, postoperative day 1, day 7 and day 30
Change in corneal hysteresis measured by Ocular response analyzer before cataract surgery and at postoperative day 1, day 7 and day 30. Changes will be compared between patients with pseudoexfoliation syndrome and controls.
1 secondary outcome
Change in corneal resistance factor (CRF)
Time frame: Baseline, postoperative day 1, day 7 and day 30
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 23 Jul 2026.
- Individual participant dataSharing planned: No
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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 4 inclusion and 8 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: opening soon, as of the sponsor's last update on 23 Jul 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?
Change in corneal hysteresis (CH) (time frame: Baseline, postoperative day 1, day 7 and 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 23 Jul 2026.