Cataract, Inflammation, Posterior Capsule Opacification, Uveitis
Conditions
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
Interventions
DEVICEHydrophobic IOL: Vivinex (HOYA)
Patients requiring cataract surgery will be randomized to one of the two types of IOLs.
DEVICEHydrophilic IOL: INCISE (Bausch+Lomb)
Patients requiring cataract surgery will be randomized to one of the two types of IOLs.
Sponsors
Vastra Gotaland Region
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in inflammatory response | Preoperatively and at seven occasions within two years postoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of posterior capsule opacification after six months | Six months (plus or minus 30 days) postoperatively | — |
| Evaluation of posterior capsule opacification after one year | One year (plus or minus 30 days) postoperatively | — |
| Evaluation of posterior capsule opacification after two years | Two years (plus or minus 2 months) postoperatively | — |
| Change in best corrected visual acuity assessed in decimal using Snellen charts | Preoperatively and at six occasions within two years postoperatively | — |
| Complications | Preoperatively and at seven occasions within two years postoperatively | Postoperative glaucoma or cystoid macular edema |
Countries
Sweden
Outcome results
None listed