Modification of Scleral Suture Fixation of Dislocated IOL

Not Applicable

Completed

• Conditions: Dislocated Intraocular Lens
• Interventions: Procedure: Intraocular lens (IOL) ab externo scleral suture fixation; Procedure: Modified IOL ab externo scleral suture fixation

• Registration Number: NCT04150263
• Lead Sponsor: St. Erik Eye Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-11-12
• Study First Submitted: 2019-10-29
• Study First Submitted QC: 2019-10-31
• Study First Posted: 2019-11-04
• Primary Completion: 2023-05-12
• Study Completion: 2023-05-12
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 117

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional IOL repositioning	Intraocular lens (IOL) ab externo scleral suture fixation	Intraocular lens (IOL) ab externo scleral suture fixation
Modification of traditional IOL repositioning	Modified IOL ab externo scleral suture fixation	Modified intraocular lens (IOL) ab externo scleral suture fixation

Primary Outcome Measures

Name	Time	Method
Astigmatism	through study completion, an average of 1,5 years	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,
IOL position	through study completion, an average of 1,5 years	Measured at 3 time points: 1 month, 6 months and 1.5 years postoperatively, with anterior optical coherence tomography (OCT).
Capsular thickness	preoperatively or as soon as possible postoperatively	Measured with OCT and photographed on slit-lamp examination.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Laura Armonaite; 🇸🇪 Stockholm, Sweden