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

Intraocular Lens Dislocation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01784926
• Other study ID #: 2012/1981
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2013
• Est. completion date: December 2020

Study information

• Verified date: September 2019
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 104
• Est. completion date: December 2020
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Intraocular Lens Dislocation
• Lens Subluxation

Intervention

Procedure:
• Intraocular lens repositioning by scleral suturing

• Intraocular lens exchange with retropupillary iris-claw lens

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best Corrected Visual Acuity (BCVA)	Measure for visual function. Measured in logMAR	6 months, 1 year and 2 years
Primary	Intraocular Pressure (IOP)	Measure for the pressure inside the eye, measured with Goldman applanation tonometer, in mmHg.	6 months and 2 years
Primary	Endothelial Density	Corneal endothelial cell density (ECD), measured by confocal microscopy. Reported in cells per square millimeter	6 months
Primary	Postoperative Complications	Cystoid macular edema considered the most important long-term complication and therefore reported here.	6 months and 2 years
Secondary	Keratometry	Keratometry of the cornea. Corneal astigmatism, measured in diopters.	6 months (only analyzed/reported for this time frame)
Secondary	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)
Secondary	IOL Location	Measure IOL's location with slit lamp and Pentacam.	2 years