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OpenTrials
Completed

NCT Number: NCT02975895

Outcome of Different IOLs in Patients With and Without Uveitis

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

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Key information

Conditions

Uveitis Cataract Eye Diseases Inflammation Lens Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Posterior Capsule Opacification Uveal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vastra Gotaland Region, Sahlgrenska University Hospital, Department of Ophthalmology

Mölndal, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Hydrophobic IOL: Vivinex (HOYA)

Device

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

Hydrophilic IOL: INCISE (Bausch+Lomb)

Device

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

Primary outcomes

  1. Change in inflammatory response

    Time frame: Preoperatively and at seven occasions within two years postoperatively

Secondary outcomes

  1. Evaluation of posterior capsule opacification after six months

    Time frame: Six months (plus or minus 30 days) postoperatively

  2. Evaluation of posterior capsule opacification after one year

    Time frame: One year (plus or minus 30 days) postoperatively

  3. Evaluation of posterior capsule opacification after two years

    Time frame: Two years (plus or minus 2 months) postoperatively

  4. Change in best corrected visual acuity assessed in decimal using Snellen charts

    Time frame: Preoperatively and at six occasions within two years postoperatively

  5. Complications

    Time frame: Preoperatively and at seven occasions within two years postoperatively

    Postoperative glaucoma or cystoid macular edema

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2021
Study completion
2022
First posted
Nov 29, 2016
Registry last updated
Aug 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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