Modification of Scleral Suture Fixation of Dislocated IOL

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-12

Study Completion Date

2023-05-12

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.

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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.

Conditions

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Dislocated Intraocular Lens

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1 arm included 56 patients, the other arm included 61 patients. Sixty controls with ordinary pseudophakia.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Traditional IOL repositioning

Intraocular lens (IOL) ab externo scleral suture fixation

Group Type OTHER

Intraocular lens (IOL) ab externo scleral suture fixation

Intervention Type PROCEDURE

traditional IOL scleral suture fixation

Modification of traditional IOL repositioning

Modified intraocular lens (IOL) ab externo scleral suture fixation

Group Type OTHER

Modified IOL ab externo scleral suture fixation

Intervention Type PROCEDURE

Modified IOL scleral suture fixation

Interventions

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Intraocular lens (IOL) ab externo scleral suture fixation

traditional IOL scleral suture fixation

Intervention Type PROCEDURE

Modified IOL ab externo scleral suture fixation

Modified IOL scleral suture fixation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients with in-the-bag dislocated IOL who agree to participate in the study

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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No