Modification of Scleral Suture Fixation of Dislocated IOL

NCT04150263 | Completed

• 1 other identifier: 2018/1838 - 31/2
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

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.

Conditions

Dislocated Intraocular Lens

Keywords

intraocular lens, dislocation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Best Corrected Visual Acuity (BCVA)

  through study completion, an average of 1,5 years

• Intraocular Pressure (IOP)

  through study completion, an average of 1,5 years

• administration of IOL lowering therapy

  through study completion, an average of 1,5 years

• Number of participants with postoperative complications

  through study completion, an average of 1,5 year

• Precision of the IOL position measurement with OCT

  1 month or any other postoperative control through study completion, an average of 1,5 year

Study Arms (2)

Traditional IOL repositioning

OTHER

Intraocular lens (IOL) ab externo scleral suture fixation

Procedure: Intraocular lens (IOL) ab externo scleral suture fixation

Modification of traditional IOL repositioning

OTHER

Modified intraocular lens (IOL) ab externo scleral suture fixation

Procedure: Modified IOL ab externo scleral suture fixation

Interventions

Intraocular lens (IOL) ab externo scleral suture fixation PROCEDURE

traditional IOL scleral suture fixation

Traditional IOL repositioning

Modified IOL ab externo scleral suture fixation PROCEDURE

Modified IOL scleral suture fixation

Modification of traditional IOL repositioning

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Erik Eye Hospital: lead
• Umeå University: collaborator

Study Sites (1)

Laura Armonaite

Stockholm, Sweden

Location

MeSH Terms

Conditions

Joint Dislocations

Interventions

Lenses, Intraocular

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies; Prostheses and Implants

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

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

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: November 4, 2019
• Study Start: November 12, 2018
• Primary Completion: May 12, 2023
• Study Completion: May 12, 2023
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)