Outcome of Different IOLs in Patients With and Without Uveitis

NCT02975895 | Completed

• 1 other identifier: 031-16
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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

Conditions

Uveitis; Cataract; Inflammation; Posterior Capsule Opacification

Outcome Measures

Primary Outcomes (1)

• Change in inflammatory response

  Preoperatively and at seven occasions within two years postoperatively

Secondary Outcomes (5)

• 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

Study Arms (2)

Hydrophobic IOL: Vivinex (HOYA)

OTHER

Intraocular lens with hydrophobic properties: Vivinex (HOYA).

Device: Hydrophobic IOL: Vivinex (HOYA)

Hydrophilic IOL: INCISE (Bausch+Lomb)

OTHER

Intraocular lens with hydrophilic properties: INCISE (Bausch+Lomb).

Device: Hydrophilic IOL: INCISE (Bausch+Lomb)

Interventions

Hydrophobic IOL: Vivinex (HOYA) DEVICE

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

Hydrophobic IOL: Vivinex (HOYA)

Hydrophilic IOL: INCISE (Bausch+Lomb) DEVICE

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

Hydrophilic IOL: INCISE (Bausch+Lomb)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cataract requiring surgery
• Ability to understand and sign consent form

You may not qualify if:

• Extensive corneal scarring
• Unregulated glaucoma
• Intraoperative complications (capsular tear or vitreous loss)

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (1)

Vastra Gotaland Region, Sahlgrenska University Hospital, Department of Ophthalmology

Mölndal, Sweden

Location

MeSH Terms

Conditions

Uveitis; Cataract; Inflammation

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases; Lens Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Madeleine Zetterberg, MD, PhD

  Västra Götalands regionen, Sahlgrenska University Hospital, Department of Ophthalmology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2016
• First Posted: November 29, 2016
• Study Start: December 30, 2016
• Primary Completion: February 22, 2021
• Study Completion: March 17, 2022
• Last Updated: August 30, 2023

Record last verified: 2023-08

Locations

SE (1)