- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02975895
Outcome of Different IOLs in Patients With and Without Uveitis
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
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Mölndal, Sweden
- Vastra Gotaland Region, Sahlgrenska University Hospital, Department of Ophthalmology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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
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Preoperatively and at seven occasions within two years postoperatively
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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
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Six months (plus or minus 30 days) postoperatively
|
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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
|
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Evaluation of posterior capsule opacification after two years
Time Frame: Two years (plus or minus 2 months) postoperatively
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Two years (plus or minus 2 months) postoperatively
|
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Change in best corrected visual acuity assessed in decimal using Snellen charts
Time Frame: Preoperatively and at six occasions within two years postoperatively
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Preoperatively and at six occasions within two years postoperatively
|
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Complications
Time Frame: Preoperatively and at seven occasions within two years postoperatively
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Postoperative glaucoma or cystoid macular edema
|
Preoperatively and at seven occasions within two years postoperatively
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Madeleine Zetterberg, MD, PhD, Västra Götalands regionen, Sahlgrenska University Hospital, Department of Ophthalmology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 031-16
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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