Long-term Intraocular Lens (IOL) Decentration and Tilt in Eyes With Pseudoexfoliation Syndrome (PES) Following Cataract Surgery

• Sponsor: Hospital Hietzing (Other)
• Overall Status: Completed
• CT.gov ID: NCT03453827
• Collaborator: (none)
• Enrollment: 37
• Actual Duration (Months): 12.9

Study Details

Study Description

Brief Summary

To evaluate long-term intraocular lens (IOL) decentration and tilt in eyes with pseudoexfoliation syndrome (PES) following cataract surgery using Visante anterior segment OCT and iTrace Visual Function Analyzer.

Condition or Disease	Intervention/Treatment	Phase
Cataract; Pseudoexfoliation Syndrome; Pseudophakia	Other: no intervention

Detailed Description

64 eyes following cataract surgery from 2009 to 2012 were included, 34 eyes had PES, 30 eyes did not show PES. A standard phacoemulsification procedure followed by IOL implantation was performed and patients were followed 4-6 years after surgery (mean=69 months). Best corrected visual acuity (BCVA), intraocular pressure (IOP) and capsulorhexis size were measured. IOL tilt and IOL decentration were evaluated using Visante Omni anterior segment OCT (Carl Zeiss Jena GmBH, Germany). The iTrace VFA (Visual Function Analyzer, Topcon Medical Systems, Inc.) was used to measure internal, corneal and total optical aberrations.

Study Design

• Study Type: Observational
• Actual Enrollment: 37 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: Assessment of Long-term Intraocular Lens (IOL) Decentration and Tilt in Eyes With Pseudoexfoliation Syndrome (PES) Following Cataract Surgery
• Actual Study Start Date: Apr 1, 2016
• Actual Primary Completion Date: Apr 28, 2017
• Actual Study Completion Date: Apr 28, 2017

Arms and Interventions

Arm	Intervention/Treatment
PEX Patients after Cataract surgery with PES	Other: no intervention; no intervention
Control Patients after Cataract surgery without PES	Other: no intervention; no intervention

Outcome Measures

Primary Outcome Measures

1. IOL decentration [4-6 years after cataract surgery]

   decentration of IOL is measured using Hoya iTrace

2. IOL tilt [4-6 years after cataract surgery]

   tilt of implanted IOL is measured using Hoya iTace

3. IOL decentration [4-6 years after cataract surgery]

   decentration of IOL is measured using Zeiss OCT

4. IOL tilt [4-6 years after cataract surgery]

   tilt of implanted IOL is measured using Zeiss OCT

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 125 Years
• Sexes Eligible for Study: All

Inclusion Criteria:

• patients 4-6 years after standard cataract surgery

• pseudoexfoliation Syndrome (PES)

Exclusion Criteria:

• Diabetic retinopathy

• Age related macula Degeneration

• retinal bloodvessel disease

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Hospital Hietzing

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kata Mihaltz, Oberarzt M.D. PhD FEBO, Hospital Hietzing
• ClinicalTrials.gov Identifier: NCT03453827
• Other Study ID Numbers: PEX Study
• First Posted: Mar 5, 2018
• Last Update Posted: Mar 8, 2018
• Last Verified: Mar 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Kata Mihaltz, Oberarzt M.D. PhD FEBO, Hospital Hietzing: Pseudoexfoliation Syndrome; Cataract; Aberration; IOL decentration; IOL tilt
• Additional relevant MeSH terms: Cataract; Exfoliation Syndrome; Syndrome; Pseudophakia

Study Results

No Results Posted as of Mar 8, 2018