Modification of Scleral Suture Fixation of Dislocated IOL

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Dislocated Intraocular Lens
• Intervention / Treatment: Procedure: Intraocular lens (IOL) ab externo scleral suture fixation; Procedure: Modified IOL ab externo scleral suture fixation

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden
    • Laura Armonaite

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Traditional IOL repositioning; Intraocular lens (IOL) ab externo scleral suture fixation	Procedure: Intraocular lens (IOL) ab externo scleral suture fixation; traditional IOL scleral suture fixation
Other: Modification of traditional IOL repositioning; Modified intraocular lens (IOL) ab externo scleral suture fixation	Procedure: Modified IOL ab externo scleral suture fixation; Modified IOL scleral suture fixation

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: St. Erik Eye Hospital
• Collaborators: Umeå University

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2018
• Primary Completion (Estimated): November 1, 2023
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: October 29, 2019
• First Submitted That Met QC Criteria: October 31, 2019
• First Posted (Actual): November 4, 2019

Study Record Updates

• Last Update Posted (Estimated): June 19, 2023
• Last Update Submitted That Met QC Criteria: June 16, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: intraocular lens, dislocation
• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Joint Dislocations
• Other Study ID Numbers: 2018/1838 - 31/2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No