Outcome of Different IOLs in Patients With and Without Uveitis

NCT ID: NCT02975895

Last Updated: 2023-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-30

Study Completion Date

2022-03-17

Brief Summary

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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

Detailed Description

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Conditions

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Uveitis Cataract Inflammation Posterior Capsule Opacification

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Hydrophobic IOL: Vivinex (HOYA)

Intraocular lens with hydrophobic properties: Vivinex (HOYA).

Group Type OTHER

Hydrophobic IOL: Vivinex (HOYA)

Intervention Type DEVICE

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).

Group Type OTHER

Hydrophilic IOL: INCISE (Bausch+Lomb)

Intervention Type DEVICE

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

Interventions

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Hydrophobic IOL: Vivinex (HOYA)

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

Intervention Type DEVICE

Hydrophilic IOL: INCISE (Bausch+Lomb)

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

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vastra Gotaland Region

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Madeleine Zetterberg, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Västra Götalands regionen, Sahlgrenska University Hospital, Department of Ophthalmology

Locations

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Vastra Gotaland Region, Sahlgrenska University Hospital, Department of Ophthalmology

Mölndal, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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031-16

Identifier Type: -

Identifier Source: org_study_id

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