Modification of Scleral Suture Fixation of Dislocated IOL

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. Two surgical techniques of suturing of IOL to the sclera will be compared in the study. IOL position will be compared between those two groups, as well to a control group consisting of ordinary pseudophakia where only measurement of IOL position will be performed.

Detailed Description
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In this prospective randomized study 60 patients will be included with late intraocular lens (IOL) dislocation and 60 patients in a control group with ordinary pseudophakia. Traditional surgery includes a capsular-IOL complex fixation to sclera by looping a prolene suture not only around haptics but also through capsular tissue. Such a suture may cut through the bag, which may result in a decentered IOL. A modification of the traditional method was created at S:t Eriks Eye Hospital in order to achieve better centration of the IOL. The study will evaluate the efficacy of these two methods. Additionally, the impact of fibrosis of capsular bag on IOL stability postoperatively will be evaluated.

Official Title
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Dislocated Intraocular Lenses: Effect of Modification of Surgical Repositioning and Capsular Fibrosis Impact on Position of IOL After Fixation Surgery in a Randomized Trial

Conditions
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Dislocated Intraocular Lens

Intervention / Treatment
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* Procedure: Intraocular lens (IOL) ab externo scleral suture fixation
* Procedure: Modified IOL ab externo scleral suture fixation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with in-the-bag dislocated IOL who agree to participate in the study Inclusion criteria for the control group: pseudophakic eyes 7-10 years after uneventful cataract surgery. Exclusion Criteria: patients with dislocated IOL that is not visible in the pupillary plane IOL design not suitable for suturing using capsular bag patients who are not able to cooperate under measurements patients with Marfan syndrome and ectopia lentis exclusion criterion for the control group: other eye surgery.
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: Traditional IOL repositioning<br>Intraocular lens (IOL) ab externo scleral suture fixation | Procedure: Intraocular lens (IOL) ab externo scleral suture fixation<br>* traditional IOL scleral suture fixation<br>|
| Other: Modification of traditional IOL repositioning<br>Modified intraocular lens (IOL) ab externo scleral suture fixation | Procedure: Modified IOL ab externo scleral suture fixation<br>* Modified IOL scleral suture fixation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOL position | Measured at 3 time points: 1 month, 6 months and 1.5 years postoperatively, with anterior optical coherence tomography (OCT). | through study completion, an average of 1,5 years | 
| Capsular thickness | Measured with OCT and photographed on slit-lamp examination. | preoperatively or as soon as possible postoperatively | 
| Astigmatism | Measured with corneal topography, autorefractometer and keratometer. Corneal and IOL related astigmatism measured in diopters.Measured at 3 time points: 1 month, 6 months and 1.5 years postoperatively, | through study completion, an average of 1,5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Corrected Visual Acuity (BCVA) | Measure for visual function. Measured in logMAR. Measured preoperatively, 1 month, 6 months and 1.5 years postoperatively | through study completion, an average of 1,5 years | 
| Intraocular Pressure (IOP) | Measure for the pressure inside the eye measured with Goldman applanation tonometer and iCare, both in mmHg. Measured preoperatively, 1 month, 6 months and 1.5 years postoperatively | through study completion, an average of 1,5 years | 
| administration of IOL lowering therapy | number of patients who used IOL lowering therapy | through study completion, an average of 1,5 years | 
| Number of participants with postoperative complications | Number of patients with retinal detachment, macular edema and other. | through study completion, an average of 1,5 year | 
| Precision of the IOL position measurement with OCT | Measurements of IOL position with OCT will be done 3 times by the same investigator in both mydriatic and non-mydriatic pupil status. | 1 month or any other postoperative control through study completion, an average of 1,5 year | 
| inflammation in anterior chamber | Measured at 2 time points: 6 months and 1.5 years postoperatively, with laser flare meter. | through study completion, an average of 1,5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intraocular lens, dislocation