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

Oslo University Hospital104 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

104

Conditions

Intraocular Lens Dislocation

Interventions

Intraocular lens repositioning by scleral suturingPROCEDURE

Intraocular lens exchange with retropupillary iris-claw lensPROCEDURE

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Oslo University Hospital

Oslo, Norway

Outcomes

Primary Outcomes

Best Corrected Visual Acuity (BCVA)

Measure for visual function. Measured in logMAR

Time frame: 6 months, 1 year and 2 years

Intraocular Pressure (IOP)

Measure for the pressure inside the eye, measured with Goldman applanation tonometer, in mmHg.

Time frame: 6 months and 2 years

Endothelial Density

Corneal endothelial cell density (ECD), measured by confocal microscopy. Reported in cells per square millimeter

Time frame: 6 months

Postoperative Complications

Cystoid macular edema considered the most important long-term complication and therefore reported here.

Time frame: 6 months and 2 years

Secondary Outcomes

Keratometry

Keratometry of the cornea. Corneal astigmatism, measured in diopters.

Time frame: 6 months (only analyzed/reported for this time frame)

Questionnaire Visual Function-14 (VF-14) Score

Questionnaire considering subjective visual function, scale 0-100 (higher scores mean better subjective visual outcome, lower scores means worse outcome).

Time frame: 6 months (only analyzed/reported for this time frame)

IOL Location

Measure IOL's location with slit lamp and Pentacam.

Time frame: 2 years

Data from ClinicalTrials.gov

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