NCT07719101

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
2mo left

Started Jul 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress17%
Jul 2026Oct 2026

First Submitted

Initial submission to the registry

July 17, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

July 20, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 22, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

July 23, 2026

Status Verified

July 1, 2026

Enrollment Period

2 months

First QC Date

July 17, 2026

Last Update Submit

July 21, 2026

Conditions

Pseudoexfoliation SyndromeCataract

Keywords

corneal biomechanicscorneal hysteresiscorneal resistance factorpseudoexfoliation syndromecataract surgery

Outcome Measures

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.

    Baseline, postoperative day 1, day 7 and day 30

Secondary Outcomes (1)

  • Change in corneal resistance factor (CRF)

    Baseline, postoperative day 1, day 7 and day 30

Study Arms (2)

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.

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eye Clinic Medic Jukic

Split, Splitsko-dalmatinska County, 21000, Croatia

Location

MeSH Terms

Conditions

Exfoliation SyndromeCataract

Condition Hierarchy (Ancestors)

Iris DiseasesUveal DiseasesEye DiseasesLens Diseases

Central Study Contacts

Kata Culina, MD, PhD

CONTACT

+38598615556kculina@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal investigator, Ophthalmologist

Study Record Dates

First Submitted

July 17, 2026

First Posted

July 22, 2026

Study Start

July 20, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

July 23, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

CR(1)