Outcome of Different IOLs in Patients With and Without Uveitis

Vastra Gotaland Region56 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Uveitis Cataract Inflammation Posterior Capsule Opacification

Interventions

Hydrophobic IOL: Vivinex (HOYA)DEVICE

Patients requiring cataract surgery will be randomized to one of the two types of IOLs.

Hydrophilic IOL: INCISE (Bausch+Lomb)DEVICE

Patients requiring cataract surgery will be randomized to one of the two types of IOLs.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Change in inflammatory response

Time frame: Preoperatively and at seven occasions within two years postoperatively

Secondary Outcomes

Evaluation of posterior capsule opacification after six months

Time frame: 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

Evaluation of posterior capsule opacification after two years

Time frame: 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

Complications

Postoperative glaucoma or cystoid macular edema