ClinicalTrials.gg
Sign In
Not yet recruitingNCT07719101Updated Jul 23, 2026

Influence of Cataract Surgery on Corneal Biomechanical Properties in Patients With Pseudoexfoliation Syndrome

An observational study in Pseudoexfoliation Syndrome and Cataract, sponsored by Kata Culina. Not yet recruiting at 1 site in Croatia. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-07-23.

Sponsored by Kata Culina · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
70
Ages
50 Years to 85 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Pseudoexfoliation Syndrome
  • Cataract

Keywords

  • corneal biomechanics
  • corneal hysteresis
  • corneal resistance factor
  • pseudoexfoliation syndrome
  • cataract surgery
03

In context

Exfoliation 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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
50 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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

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.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
70 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: Baseline, postoperative day 1, day 7 and day 30

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jul 2026; primary completion for Oct 2026, 3 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 17, 2026
First posted
Jul 22, 2026
StartEst.
Jul 20, 2026
Primary completionEst.
Oct 2026
CompletionEst.
Oct 2026
Last update
Jul 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07719101
Lead sponsor
Kata Culina
Responsible party
Kata Culina (Principal investigator, Ophthalmologist, Eye Clinic Medic Zuljan Jukic) — Sponsor-investigator
First posted
Jul 22, 2026
Start date
Jul 20, 2026 (estimated)
Primary completion
Oct 2026 (estimated)
Completion
Oct 2026 (estimated)
Last update
Jul 23, 2026

Study contacts

Kata Culina, MD, PhD
Contact
kculina@yahoo.com
+38598615556

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Exfoliation Syndrome →

Other studies from this sponsor

Kata Culina

Start the discussion