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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Intraocular Lens Dislocation

Intervention / Treatment
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* Procedure: Intraocular lens repositioning by scleral suturing
* Procedure: Intraocular lens exchange with retropupillary iris-claw lens


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cataract surgery, scleral suturing, Verisyse, Late in-the-bag IOL dislocation