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Outcome of Different IOLs in Patients With and Without Uveitis

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ClinicalTrials.gov Identifier: NCT02975895
Recruitment Status : Recruiting
First Posted : November 29, 2016
Last Update Posted : May 25, 2017
Sponsor:
Information provided by (Responsible Party):
Vastra Gotaland Region

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


Condition or disease Intervention/treatment Phase
Uveitis Cataract Inflammation Posterior Capsule Opacification Device: Hydrophobic IOL: Vivinex (HOYA) Device: Hydrophilic IOL: INCISE (Bausch+Lomb) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Outcome With Hydrophobic and Hydrophilic Intraocular Lens in Patients With and Without Uveitis
Study Start Date : December 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Hydrophobic IOL: Vivinex (HOYA)
Intraocular lens with hydrophobic properties: Vivinex (HOYA).
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)
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.




Primary Outcome Measures :
  1. Change in inflammatory response [ Time Frame: Preoperatively and at seven occasions within two years postoperatively ]

Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02975895


Contacts
Contact: Sara Pålsson, MD 0046-735832061 sara.palsson@vgreion.se

Locations
Sweden
Vastra Gotaland Region, Sahlgrenska University Hospital, Department of Ophthalmology Recruiting
Mölndal, Sweden
Contact: Madeleine Zetterberg, MD, PhD         
Sponsors and Collaborators
Vastra Gotaland Region
Investigators
Principal Investigator: Madeleine Zetterberg, MD, PhD Västra Götalands regionen, Sahlgrenska University Hospital, Department of Ophthalmology

Responsible Party: Vastra Gotaland Region
ClinicalTrials.gov Identifier: NCT02975895     History of Changes
Other Study ID Numbers: 031-16
First Posted: November 29, 2016    Key Record Dates
Last Update Posted: May 25, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Inflammation
Cataract
Uveitis
Capsule Opacification
Pathologic Processes
Lens Diseases
Eye Diseases
Uveal Diseases