Late In-the-bag intraOcular Lens dislocatioN Surgery

Study Overview
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Brief Summary
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Overall aim of the study is to compare the safety and efficacy of two different surgical methods to treat Late In-the-bag intraocular lens dislocation.

Detailed Description
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Cataract is a condition of unclear lens that cause poor vision. The only treatment is surgery where the blurred biological lens is replaced with an artificial clear lens (IOL). Most people who operate achieve full vision. Nevertheless, serious complications may occasionally occur, and one of these is dislocation of the entire complex with IOL and lens capsule. This requires surgical treatment. In this study the investigators want to compare two different surgical methods used in late dislocation of IOL inside the capsule after cataract surgery. Patients will be randomly affiliated to either the suturing of existing IOL / capsule complex, or lens exchange to an IOL fixed to the iris. The focus of the trial will be especially on complications and other eye changes in the early stages of surgery. Today, little data is available on these topics, and the investigators believe that new knowledge can bring us closer to a response to preferred operating techniques and an optimal drug drop regime for the patient group.

Official Title
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Late In-the-bag intraOcular Lens dislocatioN Surgery: A Randomized Clinical Trial (LION Trial)

Conditions
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Intraocular Lens Dislocation

Intervention / Treatment
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* Procedure: IOL repositioning
* Procedure: IOL exchange


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: IOL inside the capsule (in-the-bag) Late dislocation (more than 6 months after cataract surgery) IOL visible in the pupillary area in the supine position and hence possible to perform surgery with an anterior approach Eligibility for both operation methods Ability to cooperate fairly well during the examinations Willing to participate in the study, e.g. willingness to participate at all control visits Exclusion Criteria: IOL designs that cannot be repositioned with a suture loop, such as plate-haptic IOLs without holes in the peripheral part Eyes with especially thin sclera Active uveitis or pronounced iris pathology Eyes with previously performed Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK) Totally dislocated IOL into the posterior segment of the eye requiring pars plana vitrectomy Eyes that prior to cataract extraction had a subluxated lens in need of surgery with a Cionni capsular tension ring (e.g. patients with Marfan syndrome and ectopia lentis) Cases requiring a change in refraction. Risk of severe anisometropia Patients unable to lie in supine position for surgery in local anesthesia, e.g. severe chronic obstructive pulmonary disease and severe heart failure Patients using anticoagulants that cannot be discontinued For patients with dislocated IOLs in both eyes during the study period, only the first operated eye will be included. Patients without prospects of improvement in vision will be excluded.
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
Interventional Model Description: Randomized clinical trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IOL repositioning group<br> | Procedure: IOL repositioning<br>* Intraocular lens repositioning by scleral suturing<br>|
| Active Comparator: IOL exchange group<br> | Procedure: IOL exchange<br>* Intraocular lens exchange with retropupillary iris-claw lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammation in the anterior chamber after surgery | Measured with a Laser Flare Meter | The first weeks after surgery | 
| Changes in macular thickness and occurrence of Cystoid macular edema | Evaluated with Optical Coherence Tomography | The first months after surgery, and long term changes months up to two years after surgery | 
| Intraocular pressure changes | Measured with Goldmann Applanation Tonometry and iCare, both measured in mmhg | Early changes in the first weeks after surgery, and long term changes months up to two years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Corrected Visual acuity (BCVA) | Measured in LogMar | Short term (the first weeks and up to 6 months) and long term (up to two years) | 
| Best Corrected Visual acuity (BCVA) | Measured in Snellen | Short term (the first weeks and up to 6 months) and long term (up to two years) | 
| Glare | Measured by straylight meter | Medium term (6 months) | 
| Glare | Measured by subjective presence of glare | Medium term (6 months) | 
| Endothelial cells | Measured by Non-contact corneal confocal microscopy | Short term (2 weeks) and long term (6months and 2 years) | 
| Intra- and postoperative complications | All relevant complications | Short term and long term (first post operative day, the first weeks and months, and up to two years) | 
| IOL tilt | Measured with anterior segment Ultra Sound | 6 months and 2 years | 
| IOL tilt | Measured with Anterior segment optical coherence tomography | 6 months and 2 years | 
| Refractive outcomes - subjective refraction measured with a phoropter | To compare the refractive outcomes (short and long-term) | Short term - meaning 2 weeks to 6 months. Long term - meaning up to two years | 
| Refractive outcomes - subjective refraction measured with a phoropter | To determine whether suture placement for IOL repositioning affects the refractive outcome | Short term - meaning 2 weeks to 6 months. Long term - meaning up to two years | 
| Astigmatism | To compare astigmatism measured by keratometry | Short term - meaning 2 weeks to 6 months. Long term - meaning up to two years | 
| Astigmatism | To compare astigmatism measured by subjective refraction measured with phoropter | Short term - meaning 2 weeks to 6 months. Long term - meaning up to two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IOL dislocation, Cataract, Cataract surgery, Scleral suturing, Verisyse, Iris-claw, Late in-the-bag IOL dislocation