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

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.

Study Overview

• Status: Unknown
• Conditions: Intraocular Lens Dislocation
• Intervention / Treatment: Procedure: Intraocular lens repositioning by scleral suturing; Procedure: Intraocular lens exchange with retropupillary iris-claw lens

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 Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway
    • Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: IOL repositioning; Operation method: Intraocular lens repositioning by scleral suturing	Procedure: Intraocular lens repositioning by scleral suturing
Other: IOL exchange; Operation method: Intraocular lens exchange with retropupillary iris-claw lens	Procedure: Intraocular lens exchange with retropupillary iris-claw lens

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Keratometry	Keratometry of the cornea. Corneal astigmatism, measured in diopters.	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).	6 months (only analyzed/reported for this time frame)
IOL Location	Measure IOL's location with slit lamp and Pentacam.	2 years

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Study Chair: Liv Drolsum, MD, PhD, Oslo University Hospital

Publications and helpful links

General Publications

• Dalby M, Drolsum L, Kristianslund O. Repositioning surgery of different intraocular lens designs in eyes with late in-the-bag intraocular lens dislocation. J Cataract Refract Surg. 2021 Sep 1;47(9):1147-1152. doi: 10.1097/j.jcrs.0000000000000588.
• Kristianslund O, Ostern AE, Drolsum L. Astigmatism and Refractive Outcome After Late In-The-Bag Intraocular Lens Dislocation Surgery: A Randomized Clinical Trial. Invest Ophthalmol Vis Sci. 2017 Sep 1;58(11):4747-4753. doi: 10.1167/iovs.17-22723.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): June 1, 2016
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: January 29, 2013
• First Submitted That Met QC Criteria: February 5, 2013
• First Posted (Estimate): February 6, 2013

Study Record Updates

• Last Update Posted (Actual): September 27, 2019
• Last Update Submitted That Met QC Criteria: September 2, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: cataract surgery; Verisyse; Late in-the-bag IOL dislocation; scleral suturing
• Additional Relevant MeSH Terms: Eye Diseases; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Lens Diseases; Cataract; Joint Dislocations; Lens Subluxation
• Other Study ID Numbers: 2012/1981