NCT03453827

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2016

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 5, 2018

Completed
Last Updated

March 8, 2018

Status Verified

March 1, 2018

Enrollment Period

1.1 years

First QC Date

February 27, 2018

Last Update Submit

March 6, 2018

Conditions

CataractPseudoexfoliation SyndromePseudophakia

Keywords

Pseudoexfoliation SyndromeCataractAberrationIOL decentrationIOL tilt

Outcome Measures

Primary Outcomes (4)

  • IOL decentration

    decentration of IOL is measured using Hoya iTrace

    4-6 years after cataract surgery

  • IOL tilt

    tilt of implanted IOL is measured using Hoya iTace

    4-6 years after cataract surgery

  • IOL decentration

    decentration of IOL is measured using Zeiss OCT

    4-6 years after cataract surgery

  • IOL tilt

    tilt of implanted IOL is measured using Zeiss OCT

    4-6 years after cataract surgery

Study Arms (2)

PEX

Patients after Cataract surgery with PES

Other: no intervention

Control

Patients after Cataract surgery without PES

Other: no intervention

Interventions

no interventionOTHER

no intervention

ControlPEX

Eligibility Criteria

Age18 Years - 125 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who underwent standard procedure cataract surgery with or without Pseudoexfoliation Syndrome.

You may qualify if:

  • patients 4-6 years after standard cataract surgery
  • pseudoexfoliation Syndrome (PES)

You may not qualify if:

  • Diabetic retinopathy
  • Age related macula Degeneration
  • retinal bloodvessel disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

CataractExfoliation SyndromePseudophakia

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesIris DiseasesUveal DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Oberarzt M.D. PhD FEBO

Study Record Dates

First Submitted

February 27, 2018

First Posted

March 5, 2018

Study Start

April 1, 2016

Primary Completion

April 28, 2017

Study Completion

April 28, 2017

Last Updated

March 8, 2018

Record last verified: 2018-03