Skip to main content
OpenTrials
Completed

NCT Number: NCT04150263

Modification of Scleral Suture Fixation of Dislocated IOL

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dislocated Intraocular Lens Joint Diseases Joint Dislocations Musculoskeletal Diseases Wounds and Injuries

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laura Armonaite

Stockholm, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intraocular lens (IOL) ab externo scleral suture fixation

Procedure

traditional IOL scleral suture fixation

Modified IOL ab externo scleral suture fixation

Procedure

Modified IOL scleral suture fixation

Primary outcomes

  1. IOL position

    Time frame: 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).

  2. Capsular thickness

    Time frame: preoperatively or as soon as possible postoperatively

    Measured with OCT and photographed on slit-lamp examination.

  3. Astigmatism

    Time frame: 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,

Secondary outcomes

  1. Best Corrected Visual Acuity (BCVA)

    Time frame: 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

  2. Intraocular Pressure (IOP)

    Time frame: 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

  3. administration of IOL lowering therapy

    Time frame: through study completion, an average of 1,5 years

    number of patients who used IOL lowering therapy

  4. Number of participants with postoperative complications

    Time frame: through study completion, an average of 1,5 year

    Number of patients with retinal detachment, macular edema and other.

  5. Precision of the IOL position measurement with OCT

    Time frame: 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.

  6. inflammation in anterior chamber

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

St. Erik Eye Hospital

Other

Collaborators

  • Umeå University

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Nov 4, 2019
Registry last updated
Apr 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.