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

Primary Purpose

Intraocular Lens Dislocation

Status

Unknown status

Phase

Not Applicable

Locations

Norway

Study Type

Interventional

Intervention

IOL repositioning

IOL exchange

About this trial

This is an interventional treatment trial for Intraocular Lens Dislocation focused on measuring IOL dislocation, Cataract, Cataract surgery, Scleral suturing, Verisyse, Iris-claw, Late in-the-bag IOL dislocation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Oslo University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

IOL repositioning group

IOL exchange group

Arm Description

Outcomes

Primary Outcome Measures

Inflammation in the anterior chamber after surgery

Measured with a Laser Flare Meter

Changes in macular thickness and occurrence of Cystoid macular edema

Evaluated with Optical Coherence Tomography

Intraocular pressure changes

Measured with Goldmann Applanation Tonometry and iCare, both measured in mmhg

Secondary Outcome Measures

Best Corrected Visual acuity (BCVA)

Measured in LogMar

Best Corrected Visual acuity (BCVA)

Measured in Snellen

Glare

Measured by straylight meter

Glare

Measured by subjective presence of glare

Endothelial cells

Measured by Non-contact corneal confocal microscopy

Intra- and postoperative complications

All relevant complications

IOL tilt

Measured with anterior segment Ultra Sound

IOL tilt

Measured with Anterior segment optical coherence tomography

Refractive outcomes - subjective refraction measured with a phoropter

To compare the refractive outcomes (short and long-term)

Refractive outcomes - subjective refraction measured with a phoropter

To determine whether suture placement for IOL repositioning affects the refractive outcome

Astigmatism

To compare astigmatism measured by keratometry

Astigmatism

To compare astigmatism measured by subjective refraction measured with phoropter

Full Information

NCT ID

NCT03276104

First Posted

August 31, 2017

Last Updated

April 16, 2019

Sponsor

Oslo University Hospital

Collaborators

South-Eastern Norway Regional Health Authority

1. Study Identification

Unique Protocol Identification Number

NCT03276104

Brief Title

Late In-the-bag intraOcular Lens dislocatioN Surgery

Acronym

LION

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Unknown status

Study Start Date

September 9, 2017 (Actual)

Primary Completion Date

November 2020 (Anticipated)

Study Completion Date

December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Oslo University Hospital

Collaborators

South-Eastern Norway Regional Health Authority

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Intraocular Lens Dislocation

Keywords

IOL dislocation, Cataract, Cataract surgery, Scleral suturing, Verisyse, Iris-claw, Late in-the-bag IOL dislocation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomized clinical trial

Masking

Outcomes Assessor

Masking Description

Masking of research optometrists to group affiliation at the postoperative examinations will be endeavored. A physician will perform slit lamp examinations at the postoperative visits, hence he/she cannot be masked, nor can the surgeon. The investigator will be masked during the image analysis.

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

IOL repositioning group

Arm Type

Active Comparator

Arm Title

IOL exchange group

Arm Type

Active Comparator

Intervention Type

Procedure

Intervention Name(s)

IOL repositioning

Intervention Description

Intraocular lens repositioning by scleral suturing

Intervention Type

Procedure

Intervention Name(s)

IOL exchange

Intervention Description

Intraocular lens exchange with retropupillary iris-claw lens

Primary Outcome Measure Information:

Title

Inflammation in the anterior chamber after surgery

Description

Measured with a Laser Flare Meter

Time Frame

The first weeks after surgery

Title

Changes in macular thickness and occurrence of Cystoid macular edema

Description

Evaluated with Optical Coherence Tomography

Time Frame

The first months after surgery, and long term changes months up to two years after surgery

Title

Intraocular pressure changes

Description

Measured with Goldmann Applanation Tonometry and iCare, both measured in mmhg

Time Frame

Early changes in the first weeks after surgery, and long term changes months up to two years after surgery

Secondary Outcome Measure Information:

Title

Best Corrected Visual acuity (BCVA)

Description

Measured in LogMar

Time Frame

Short term (the first weeks and up to 6 months) and long term (up to two years)

Title

Best Corrected Visual acuity (BCVA)

Description

Measured in Snellen

Time Frame

Short term (the first weeks and up to 6 months) and long term (up to two years)

Title

Glare

Description

Measured by straylight meter

Time Frame

Medium term (6 months)

Title

Glare

Description

Measured by subjective presence of glare

Time Frame

Medium term (6 months)

Title

Endothelial cells

Description

Measured by Non-contact corneal confocal microscopy

Time Frame

Short term (2 weeks) and long term (6months and 2 years)

Title

Intra- and postoperative complications

Description

All relevant complications

Time Frame

Short term and long term (first post operative day, the first weeks and months, and up to two years)

Title

IOL tilt

Description

Measured with anterior segment Ultra Sound

Time Frame

6 months and 2 years

Title

IOL tilt

Description

Measured with Anterior segment optical coherence tomography

Time Frame

6 months and 2 years

Title

Refractive outcomes - subjective refraction measured with a phoropter

Description

To compare the refractive outcomes (short and long-term)

Time Frame

Short term - meaning 2 weeks to 6 months. Long term - meaning up to two years

Title

Refractive outcomes - subjective refraction measured with a phoropter

Description

To determine whether suture placement for IOL repositioning affects the refractive outcome

Time Frame

Short term - meaning 2 weeks to 6 months. Long term - meaning up to two years

Title

Astigmatism

Description

To compare astigmatism measured by keratometry

Time Frame

Short term - meaning 2 weeks to 6 months. Long term - meaning up to two years

Title

Astigmatism

Description

To compare astigmatism measured by subjective refraction measured with phoropter

Time Frame

Short term - meaning 2 weeks to 6 months. Long term - meaning up to two years

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marius Dalby, M.D. PhD Cand.

Phone

+47 92408957

marius.dalby@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Liv Drolsum, Prof. M.D. PhD

Organizational Affiliation

Oslo University Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Oslo University Hospital

City

Oslo

Country

Norway

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Olav Kristianslund, M.D. M.Phil. PhD cand.

Phone

+47 41625514

olav.kristianslund@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Late In-the-bag intraOcular Lens dislocatioN Surgery

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