Overview

This trial is active, not recruiting.

Condition intraocular lens dislocation
Treatments intraocular lens repositioning by scleral suturing, intraocular lens exchange with retropupillary iris-claw lens
Sponsor Oslo University Hospital
Start date January 2013
End date June 2016
Trial size 104 participants
Trial identifier NCT01784926, 2012/1981

Summary

In this prospective, randomized study The investigators will include 80 patients with late intraocular lens (IOL) dislocation in the capsular complex, after cataract surgery. To obtain normal visual function, these patients needs surgery. Today, there are two different methods used for this condition; scleral suturing of the capsular complex or exchange of IOL to an iris-fixated IOL (Verisyse). In this study the investigators will look for advantages and dis-advantages for these two methods.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Operation method: Intraocular lens repositioning by scleral suturing
intraocular lens repositioning by scleral suturing
(Other)
Operation method: Intraocular lens exchange with retropupillary iris-claw lens
intraocular lens exchange with retropupillary iris-claw lens

Primary Outcomes

Measure
Best corrected visual acuity
time frame: 6 months
Intraocular pressure (IOP)
time frame: 6 months
Endothelial density
time frame: 6 months
Postoperative complications
time frame: 6 months

Secondary Outcomes

Measure
Keratometry
time frame: 6 months
Questionaire Visual function (VF-14)
time frame: 6 months
IOL location
time frame: 6 months

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - patients with dislocation of IOL in the capsular complex who agree to participate in the study Exclusion Criteria: - patients with total dislocation of the capsular complex' - patients with reduced general health - patients who can't be randomized

Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Oslo University Hospital.