Inflammation Clinical Trial
Official title:
Outcome With Hydrophobic and Hydrophilic Intraocular Lens in Patients With and Without Uveitis
NCT number | NCT02975895 |
Other study ID # | 031-16 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | December 30, 2016 |
Est. completion date | March 17, 2022 |
Verified date | August 2023 |
Source | Vastra Gotaland Region |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 56 |
Est. completion date | March 17, 2022 |
Est. primary completion date | February 22, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Sweden | Vastra Gotaland Region, Sahlgrenska University Hospital, Department of Ophthalmology | Mölndal |
Lead Sponsor | Collaborator |
---|---|
Vastra Gotaland Region |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in inflammatory response | Preoperatively and at seven occasions within two years postoperatively | ||
Secondary | Evaluation of posterior capsule opacification after six months | Six months (plus or minus 30 days) postoperatively | ||
Secondary | Evaluation of posterior capsule opacification after one year | One year (plus or minus 30 days) postoperatively | ||
Secondary | Evaluation of posterior capsule opacification after two years | Two years (plus or minus 2 months) postoperatively | ||
Secondary | Change in best corrected visual acuity assessed in decimal using Snellen charts | Preoperatively and at six occasions within two years postoperatively | ||
Secondary | Complications | Postoperative glaucoma or cystoid macular edema | Preoperatively and at seven occasions within two years postoperatively |
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