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

ConditionsPseudoexfoliation Syndrome Cataract

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age50-85

SponsorKata Culina

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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),

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

70 Participants

are grouped into 2 trial groups

Group A: Pseudoexfoliation syndrome

Group B: Control

Trial outcomes

Primary outcomes

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

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kata Culina

Lead sponsor

Eye Clinic Medic Zuljan Jukic

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: