Outcome of Different IOLs in Patients With and Without Uveitis

August 29, 2023 updated by: Vastra Gotaland Region

Outcome With Hydrophobic and Hydrophilic Intraocular Lens in Patients With and Without Uveitis

Cataract, is a clouding of the lens in the eye gradually leading to reduction of the visual acuity. In most cases it can be managed with surgery, removing the own lens and replacing it with an artificial lens, intraocular lens (IOL). These lenses are made in different materials with different properties.

Uveitis refers to an inflammation in the iris, ciliary body and choroid. Patients with this disease have an increased risk of developing cataract due to the inflammation itself and treatment with steroids. They also have an increased risk of complications during surgery and postoperatively. In this group the selection of IOL might be of greater importance.

The aim of this prospective randomized controlled study is to compare the outcome of hydrophobic and hydrophilic intraocular lenses in patients with and without uveitis

Study Overview

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

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

      • Mölndal, Sweden
        • Vastra Gotaland Region, Sahlgrenska University Hospital, Department of Ophthalmology

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Cataract requiring surgery
  • Ability to understand and sign consent form

Exclusion Criteria:

  • Extensive corneal scarring
  • Other eye surgery less than 3 months before inclusion
  • Unregulated glaucoma
  • Active uveitis (increased inflammation and treatment less than 3 months before inclusion)
  • Intraoperative complications (capsular tear or vitreous loss)

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Hydrophobic IOL: Vivinex (HOYA)
Intraocular lens with hydrophobic properties: Vivinex (HOYA).
Patients requiring cataract surgery will be randomized to one of the two types of IOLs.
Other: Hydrophilic IOL: INCISE (Bausch+Lomb)
Intraocular lens with hydrophilic properties: INCISE (Bausch+Lomb).
Patients requiring cataract surgery will be randomized to one of the two types of IOLs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in inflammatory response
Time Frame: Preoperatively and at seven occasions within two years postoperatively
Preoperatively and at seven occasions within two years postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of posterior capsule opacification after six months
Time Frame: Six months (plus or minus 30 days) postoperatively
Six months (plus or minus 30 days) postoperatively
Evaluation of posterior capsule opacification after one year
Time Frame: One year (plus or minus 30 days) postoperatively
One year (plus or minus 30 days) postoperatively
Evaluation of posterior capsule opacification after two years
Time Frame: Two years (plus or minus 2 months) postoperatively
Two years (plus or minus 2 months) postoperatively
Change in best corrected visual acuity assessed in decimal using Snellen charts
Time Frame: Preoperatively and at six occasions within two years postoperatively
Preoperatively and at six occasions within two years postoperatively
Complications
Time Frame: Preoperatively and at seven occasions within two years postoperatively
Postoperative glaucoma or cystoid macular edema
Preoperatively and at seven occasions within two years postoperatively

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Madeleine Zetterberg, MD, PhD, Västra Götalands regionen, Sahlgrenska University Hospital, Department of Ophthalmology

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)

December 30, 2016

Primary Completion (Actual)

February 22, 2021

Study Completion (Actual)

March 17, 2022

Study Registration Dates

First Submitted

November 15, 2016

First Submitted That Met QC Criteria

November 23, 2016

First Posted (Estimated)

November 29, 2016

Study Record Updates

Last Update Posted (Actual)

August 30, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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