ClinicalTrials.gg
Sign In
CompletedNCT03453827Updated Mar 8, 2018

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

An observational study in Cataract, Pseudoexfoliation Syndrome and Pseudophakia, sponsored by Hospital Hietzing. Completed. Open to participants aged 18 Years to 125 Years. Per ClinicalTrials.gov, last updated 2018-03-08.

Sponsored by Hospital Hietzing · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
37
Ages
18 Years to 125 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cataract
  • Pseudoexfoliation Syndrome
  • Pseudophakia

Keywords

  • Pseudoexfoliation Syndrome
  • Cataract
  • Aberration
  • IOL decentration
  • IOL tilt
03

In context

Cataract

1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.

This study's enrollment of 37 is below the median of 89 across 475 observational studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Hospital Hietzing is the lead sponsor of 15 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 125 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

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

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

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

Exclusion criteria

Exclusion Criteria:

  • Diabetic retinopathy
  • Age related macula Degeneration
  • retinal bloodvessel disease
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
37 participants (actual)
Patient registry
No

Groups and cohorts

  • PEX

    Patients after Cataract surgery with PES

    Other: no intervention

  • Control

    Patients after Cataract surgery without PES

    Other: no intervention

Interventions

  • Otherno intervention

    no intervention

06

What researchers measure

Primary outcomes

  1. IOL decentration

    decentration of IOL is measured using Hoya iTrace

    Time frame: 4-6 years after cataract surgery

  2. IOL tilt

    tilt of implanted IOL is measured using Hoya iTace

    Time frame: 4-6 years after cataract surgery

  3. IOL decentration

    decentration of IOL is measured using Zeiss OCT

    Time frame: 4-6 years after cataract surgery

  4. IOL tilt

    tilt of implanted IOL is measured using Zeiss OCT

    Time frame: 4-6 years after cataract surgery

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2016 to primary completion in Apr 2017, 12 months.

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

Registered
Feb 27, 2018
First posted
Mar 5, 2018
StartActual
Apr 1, 2016
Primary completionActual
Apr 28, 2017
CompletionActual
Apr 28, 2017
Last update
Mar 8, 2018
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 Mar 8, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03453827
Lead sponsor
Hospital Hietzing
Responsible party
Kata Mihaltz (Oberarzt M.D. PhD FEBO, Hospital Hietzing) — Principal investigator
First posted
Mar 5, 2018
Start date
Apr 1, 2016
Primary completion
Apr 28, 2017
Completion
Apr 28, 2017
Last update
Mar 8, 2018

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 completed, as verified in Mar 2018. 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

Cataract →

Other studies from this sponsor

Hospital Hietzing

Start the discussion