Positional Stability and Refractive Behaviour After Implantation of an IOL After Cataract Surgery

October 12, 2023 updated by: Matthias Bolz, Johannes Kepler University of Linz

Positional Stability and Refractive Behaviour After In-the-bag Implantation of an Aspheric Hydrophobic IOL After Conventional Phacoemulsification and Femtosecond Laser-Assisted Cataract Surgery

The newest generation Lucia 621 has a step vault design that is claimed to provide excellent positional and refractive predictability.

In order to explore the positional stability, anterior chamber depth stability is examined as marker for haptic buckling comparing positional behaviour after conventional and femtosecond-laser assisted cataract surgery.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

In order to explore the positional stability, anterior chamber depth stability is examined as marker for haptic buckling comparing positional behaviour after conventional and femtosecond-laser assisted cataract surgery.

Furthermore, the refractive outcome of CT Lucia 621P/PY is examined, providing optimized (en bloc optimization) formula constants for both, conventional and femtosecond-laser assisted cataract surgery for Haigis, Hoffer Q, Holladay I, SRK/T and Castrop formulae.

Besides ACD, further parameters for IOL stability are examined (IOL tilt/decentration) and consequences for the aberration profile are described.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Upper Austria
      • Linz, Upper Austria, Austria, 4021
        • Kepler University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Up to 50 subjects requiring IOL implantation to treat aphakia after extracapsular cataract extraction or phacoemulsification.

Description

Inclusion Criteria:

  • Adult subject with a minimum age of 22 years
  • Planned natural lens replacement with posterior chamber IOL implantation
  • Clear intraocular media other than cataract
  • Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visit
  • Ability to consent to the participation in study
  • Signed informed consent

Exclusion Criteria:

  • Corneal pathology/ectasia
  • Prior ophthalmic surgery
  • Zonular-defects, unstable bag
  • Macular pathologies
  • Expected Visual acuity of less than 0.63 (decimal)
  • Glaucoma
  • Use of systemic or ocular medication that might affect vision
  • Patient is pregnant, plans to become pregnant, is lactating
  • Concurrent participation in any other clinical trial with an investigation product

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tilt and decentration of intraocular lens measured in degrees
Time Frame: 1 month post surgery compared with 12 months post surgery
Tilt and decentration of intraocular lens measured in degrees with Casia-2 Anterior Segment Optical Coherence Tomography 1 month post surgery compared with 12 months post surgery
1 month post surgery compared with 12 months post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johannes Kepler University of Linz

Collaborators

Carl Zeiss

Investigators

  • Principal Investigator: Matthias Bolz, MD, JKU Linz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2022

Primary Completion (Estimated)

February 28, 2025

Study Completion (Estimated)

February 28, 2025

Study Registration Dates

First Submitted

August 8, 2022

First Submitted That Met QC Criteria

October 3, 2023

First Posted (Actual)

October 6, 2023

Study Record Updates

Last Update Posted (Actual)

October 16, 2023

Last Update Submitted That Met QC Criteria

October 12, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KUK-Ophthalmology-003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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