Outcome of Different IOLs in Patients With and Without Uveitis

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02975895
• Other study ID #: 031-16
• Status: Completed
• Phase: N/A
• Start date: December 30, 2016
• Est. completion date: March 17, 2022

Study information

• Verified date: August 2023
• Source: Vastra Gotaland Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• 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)

Related Conditions & MeSH terms

• Capsule Opacification
• Cataract
• Inflammation
• Posterior Capsule Opacification
• Uveitis

Intervention

Device:
• Hydrophobic IOL: Vivinex (HOYA)
Patients requiring cataract surgery will be randomized to one of the two types of IOLs.
• Hydrophilic IOL: INCISE (Bausch+Lomb)
Patients requiring cataract surgery will be randomized to one of the two types of IOLs.

Locations

Country	Name	City	State
Sweden	Vastra Gotaland Region, Sahlgrenska University Hospital, Department of Ophthalmology	Mölndal

Sponsors (1)

Lead Sponsor	Collaborator
Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

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