Outcome of Different IOLs in Patients With and Without Uveitis

Study Overview
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Brief Summary
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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

Official Title
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Outcome With Hydrophobic and Hydrophilic Intraocular Lens in Patients With and Without Uveitis

Conditions
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Uveitis, Cataract, Inflammation, Posterior Capsule Opacification

Intervention / Treatment
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* Device: Hydrophobic IOL: Vivinex (HOYA)
* Device: Hydrophilic IOL: INCISE (Bausch+Lomb)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Hydrophobic IOL: Vivinex (HOYA)<br>Intraocular lens with hydrophobic properties: Vivinex (HOYA). | Device: Hydrophobic IOL: Vivinex (HOYA)<br>* Patients requiring cataract surgery will be randomized to one of the two types of IOLs.<br>|
| Other: Hydrophilic IOL: INCISE (Bausch+Lomb)<br>Intraocular lens with hydrophilic properties: INCISE (Bausch+Lomb). | Device: Hydrophilic IOL: INCISE (Bausch+Lomb)<br>* Patients requiring cataract surgery will be randomized to one of the two types of IOLs.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in inflammatory response |  | Preoperatively and at seven occasions within two years postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Postoperative glaucoma or cystoid macular edema | Preoperatively and at seven occasions within two years postoperatively |