Late In-the-bag intraOcular Lens dislocatioN Surgery (LION)

April 16, 2019 updated by: Marius Dalby, Oslo University Hospital

Late In-the-bag intraOcular Lens dislocatioN Surgery: A Randomized Clinical Trial (LION Trial)

Overall aim of the study is to compare the safety and efficacy of two different surgical methods to treat Late In-the-bag intraocular lens dislocation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Cataract is a condition of unclear lens that cause poor vision. The only treatment is surgery where the blurred biological lens is replaced with an artificial clear lens (IOL). Most people who operate achieve full vision. Nevertheless, serious complications may occasionally occur, and one of these is dislocation of the entire complex with IOL and lens capsule. This requires surgical treatment.

In this study the investigators want to compare two different surgical methods used in late dislocation of IOL inside the capsule after cataract surgery. Patients will be randomly affiliated to either the suturing of existing IOL / capsule complex, or lens exchange to an IOL fixed to the iris.

The focus of the trial will be especially on complications and other eye changes in the early stages of surgery. Today, little data is available on these topics, and the investigators believe that new knowledge can bring us closer to a response to preferred operating techniques and an optimal drug drop regime for the patient group.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Norway
      • Oslo, Norway
        • Recruiting
        • Oslo University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • IOL inside the capsule ("in-the-bag")
  • Late dislocation (more than 6 months after cataract surgery)
  • IOL visible in the pupillary area in the supine position and hence possible to perform surgery with an anterior approach
  • Eligibility for both operation methods
  • Ability to cooperate fairly well during the examinations
  • Willing to participate in the study, e.g. willingness to participate at all control visits

Exclusion Criteria:

  • IOL designs that cannot be repositioned with a suture loop, such as plate-haptic IOLs without holes in the peripheral part
  • Eyes with especially thin sclera
  • Active uveitis or pronounced iris pathology
  • Eyes with previously performed Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK)
  • Totally dislocated IOL into the posterior segment of the eye requiring pars plana vitrectomy
  • Eyes that prior to cataract extraction had a subluxated lens in need of surgery with a Cionni capsular tension ring (e.g. patients with Marfan syndrome and ectopia lentis)
  • Cases requiring a change in refraction. Risk of severe anisometropia
  • Patients unable to lie in supine position for surgery in local anesthesia, e.g. severe chronic obstructive pulmonary disease and severe heart failure
  • Patients using anticoagulants that cannot be discontinued

For patients with dislocated IOLs in both eyes during the study period, only the first operated eye will be included. Patients without prospects of improvement in vision will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: IOL repositioning group
Procedure: IOL repositioning
Intraocular lens repositioning by scleral suturing
Active Comparator: IOL exchange group
Procedure: IOL exchange
Intraocular lens exchange with retropupillary iris-claw lens

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Inflammation in the anterior chamber after surgery
Time Frame: The first weeks after surgery
Measured with a Laser Flare Meter
The first weeks after surgery
Changes in macular thickness and occurrence of Cystoid macular edema
Time Frame: The first months after surgery, and long term changes months up to two years after surgery
Evaluated with Optical Coherence Tomography
The first months after surgery, and long term changes months up to two years after surgery
Intraocular pressure changes
Time Frame: Early changes in the first weeks after surgery, and long term changes months up to two years after surgery
Measured with Goldmann Applanation Tonometry and iCare, both measured in mmhg
Early changes in the first weeks after surgery, and long term changes months up to two years after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Best Corrected Visual acuity (BCVA)
Time Frame: Short term (the first weeks and up to 6 months) and long term (up to two years)
Measured in LogMar
Short term (the first weeks and up to 6 months) and long term (up to two years)
Best Corrected Visual acuity (BCVA)
Time Frame: Short term (the first weeks and up to 6 months) and long term (up to two years)
Measured in Snellen
Short term (the first weeks and up to 6 months) and long term (up to two years)
Glare
Time Frame: Medium term (6 months)
Measured by straylight meter
Medium term (6 months)
Glare
Time Frame: Medium term (6 months)
Measured by subjective presence of glare
Medium term (6 months)
Endothelial cells
Time Frame: Short term (2 weeks) and long term (6months and 2 years)
Measured by Non-contact corneal confocal microscopy
Short term (2 weeks) and long term (6months and 2 years)
Intra- and postoperative complications
Time Frame: Short term and long term (first post operative day, the first weeks and months, and up to two years)
All relevant complications
Short term and long term (first post operative day, the first weeks and months, and up to two years)
IOL tilt
Time Frame: 6 months and 2 years
Measured with anterior segment Ultra Sound
6 months and 2 years
IOL tilt
Time Frame: 6 months and 2 years
Measured with Anterior segment optical coherence tomography
6 months and 2 years
Refractive outcomes - subjective refraction measured with a phoropter
Time Frame: Short term - meaning 2 weeks to 6 months. Long term - meaning up to two years
To compare the refractive outcomes (short and long-term)
Short term - meaning 2 weeks to 6 months. Long term - meaning up to two years
Refractive outcomes - subjective refraction measured with a phoropter
Time Frame: Short term - meaning 2 weeks to 6 months. Long term - meaning up to two years
To determine whether suture placement for IOL repositioning affects the refractive outcome
Short term - meaning 2 weeks to 6 months. Long term - meaning up to two years
Astigmatism
Time Frame: Short term - meaning 2 weeks to 6 months. Long term - meaning up to two years
To compare astigmatism measured by keratometry
Short term - meaning 2 weeks to 6 months. Long term - meaning up to two years
Astigmatism
Time Frame: Short term - meaning 2 weeks to 6 months. Long term - meaning up to two years
To compare astigmatism measured by subjective refraction measured with phoropter
Short term - meaning 2 weeks to 6 months. Long term - meaning up to two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oslo University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
South-Eastern Norway Regional Health Authority

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Liv Drolsum, Prof. M.D. PhD, Oslo University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 9, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 31, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 8, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017/5506

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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