An interventional study of Hydrophobic IOL: Vivinex (HOYA) and Hydrophilic IOL: INCISE (Bausch+Lomb) in Uveitis, Cataract and Inflammation, sponsored by Vastra Gotaland Region. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-30.
Sponsored by Vastra Gotaland Region · Not applicable, Interventional, and Treatment
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
299 studies on the registry are indexed under Uveitis; 32 are open to participants now.
This study's enrollment of 56 is above the median of 30 across 175 interventional studies indexed under Uveitis.
Browse Uveitis studies →Vastra Gotaland Region is the lead sponsor of 275 studies on the registry; 109 are open to participants now.
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Exclusion Criteria:
Intraocular lens with hydrophobic properties: Vivinex (HOYA).
Device: Hydrophobic IOL: Vivinex (HOYA)
Intraocular lens with hydrophilic properties: INCISE (Bausch+Lomb).
Device: Hydrophilic IOL: INCISE (Bausch+Lomb)
Patients requiring cataract surgery will be randomized to one of the two types of IOLs.
Patients requiring cataract surgery will be randomized to one of the two types of IOLs.
Change in inflammatory response
Time frame: Preoperatively and at seven occasions within two years postoperatively
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
Time frame: Preoperatively and at seven occasions within two years postoperatively
Plan to share: Undecided
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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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