search
Back to results

Outcome of Different IOLs in Patients With and Without Uveitis

Primary Purpose

Uveitis, Cataract, Inflammation

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Hydrophobic IOL: Vivinex (HOYA)
Hydrophilic IOL: INCISE (Bausch+Lomb)
Sponsored by
Vastra Gotaland Region
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uveitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Hydrophobic IOL: Vivinex (HOYA)

Hydrophilic IOL: INCISE (Bausch+Lomb)

Arm Description

Intraocular lens with hydrophobic properties: Vivinex (HOYA).

Intraocular lens with hydrophilic properties: INCISE (Bausch+Lomb).

Outcomes

Primary Outcome Measures

Change in inflammatory response

Secondary Outcome Measures

Evaluation of posterior capsule opacification after six months
Evaluation of posterior capsule opacification after one year
Evaluation of posterior capsule opacification after two years
Change in best corrected visual acuity assessed in decimal using Snellen charts
Complications
Postoperative glaucoma or cystoid macular edema

Full Information

First Posted
November 15, 2016
Last Updated
August 29, 2023
Sponsor
Vastra Gotaland Region
search

1. Study Identification

Unique Protocol Identification Number
NCT02975895
Brief Title
Outcome of Different IOLs in Patients With and Without Uveitis
Official Title
Outcome With Hydrophobic and Hydrophilic Intraocular Lens in Patients With and Without Uveitis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
December 30, 2016 (Actual)
Primary Completion Date
February 22, 2021 (Actual)
Study Completion Date
March 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vastra Gotaland Region

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uveitis, Cataract, Inflammation, Posterior Capsule Opacification

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hydrophobic IOL: Vivinex (HOYA)
Arm Type
Other
Arm Description
Intraocular lens with hydrophobic properties: Vivinex (HOYA).
Arm Title
Hydrophilic IOL: INCISE (Bausch+Lomb)
Arm Type
Other
Arm Description
Intraocular lens with hydrophilic properties: INCISE (Bausch+Lomb).
Intervention Type
Device
Intervention Name(s)
Hydrophobic IOL: Vivinex (HOYA)
Intervention Description
Patients requiring cataract surgery will be randomized to one of the two types of IOLs.
Intervention Type
Device
Intervention Name(s)
Hydrophilic IOL: INCISE (Bausch+Lomb)
Intervention Description
Patients requiring cataract surgery will be randomized to one of the two types of IOLs.
Primary Outcome Measure Information:
Title
Change in inflammatory response
Time Frame
Preoperatively and at seven occasions within two years postoperatively
Secondary Outcome Measure Information:
Title
Evaluation of posterior capsule opacification after six months
Time Frame
Six months (plus or minus 30 days) postoperatively
Title
Evaluation of posterior capsule opacification after one year
Time Frame
One year (plus or minus 30 days) postoperatively
Title
Evaluation of posterior capsule opacification after two years
Time Frame
Two years (plus or minus 2 months) postoperatively
Title
Change in best corrected visual acuity assessed in decimal using Snellen charts
Time Frame
Preoperatively and at six occasions within two years postoperatively
Title
Complications
Description
Postoperative glaucoma or cystoid macular edema
Time Frame
Preoperatively and at seven occasions within two years postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Madeleine Zetterberg, MD, PhD
Organizational Affiliation
Västra Götalands regionen, Sahlgrenska University Hospital, Department of Ophthalmology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vastra Gotaland Region, Sahlgrenska University Hospital, Department of Ophthalmology
City
Mölndal
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Outcome of Different IOLs in Patients With and Without Uveitis

We'll reach out to this number within 24 hrs