Late Dislocation of Intraocular Lens (IOL) Following Cataract Surgery: an Evaluation of Two Different Surgical Methods

Not Applicable

• Conditions: Intraocular Lens Dislocation

• Registration Number: NCT01784926
• Lead Sponsor: Oslo University Hospital

Brief Summary

A prospective randomized study on patients with late in the bag intraocular lens (IOL) dislocation, after cataract surgery. To obtain normal visual function, these patients needs surgery. In this study the investigators will look for advantages and dis-advantages after two different surgical approaches to late in-the-bag IOL dislocation.

Detailed Description

In this prospective, randomized study The investigators will include at least 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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-29
• Study First Submitted QC: 2013-02-05
• Study First Posted: 2013-02-06
• Primary Completion: 2016-06
• Results First Submitted: 2017-04-19
• Status Verified: 2019-09
• Results First Submitted QC: 2019-09-02
• Last Update Submitted: 2019-09-02
• Results First Posted: 2019-09-27
• Last Update Posted: 2019-09-27
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 104

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Postoperative Complications	6 months and 2 years	Cystoid macular edema considered the most important long-term complication and therefore reported here.
Best Corrected Visual Acuity (BCVA)	6 months, 1 year and 2 years	Measure for visual function. Measured in logMAR
Intraocular Pressure (IOP)	6 months and 2 years	Measure for the pressure inside the eye, measured with Goldman applanation tonometer, in mmHg.
Endothelial Density	6 months	Corneal endothelial cell density (ECD), measured by confocal microscopy. Reported in cells per square millimeter

Secondary Outcome Measures

Name	Time	Method
Keratometry	6 months (only analyzed/reported for this time frame)	Keratometry of the cornea. Corneal astigmatism, measured in diopters.
Questionnaire Visual Function-14 (VF-14) Score	6 months (only analyzed/reported for this time frame)	Questionnaire considering subjective visual function, scale 0-100 (higher scores mean better subjective visual outcome, lower scores means worse outcome).
IOL Location	2 years	Measure IOL's location with slit lamp and Pentacam.

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway