LION: Late In-the-bag intraOcular Lens dislocatioN Surgery

Sponsor

Oslo University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03276104

Collaborator

South-Eastern Norway Regional Health Authority (Other)

Enrollment

Location

Arms

62.7

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Intraocular Lens Dislocation	Procedure: IOL repositioning Procedure: IOL exchange	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized clinical trialRandomized clinical trial

Masking:

Single (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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 9, 2017

Anticipated Primary Completion Date :

Nov 1, 2020

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Inflammation in the anterior chamber after surgery [The first weeks after surgery]
Measured with a Laser Flare Meter
Changes in macular thickness and occurrence of Cystoid macular edema [The first months after surgery, and long term changes months up to two years after surgery]
Evaluated with Optical Coherence Tomography
Intraocular pressure changes [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

Secondary Outcome Measures

Best Corrected Visual acuity (BCVA) [Short term (the first weeks and up to 6 months) and long term (up to two years)]
Measured in LogMar
Best Corrected Visual acuity (BCVA) [Short term (the first weeks and up to 6 months) and long term (up to two years)]
Measured in Snellen
Glare [Medium term (6 months)]
Measured by straylight meter
Glare [Medium term (6 months)]
Measured by subjective presence of glare
Endothelial cells [Short term (2 weeks) and long term (6months and 2 years)]
Measured by Non-contact corneal confocal microscopy
Intra- and postoperative complications [Short term and long term (first post operative day, the first weeks and months, and up to two years)]
All relevant complications
IOL tilt [6 months and 2 years]
Measured with anterior segment Ultra Sound
IOL tilt [6 months and 2 years]
Measured with Anterior segment optical coherence tomography
Refractive outcomes - subjective refraction measured with a phoropter [Short term - meaning 2 weeks to 6 months. Long term - meaning up to two years]
To compare the refractive outcomes (short and long-term)
Refractive outcomes - subjective refraction measured with a phoropter [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
Astigmatism [Short term - meaning 2 weeks to 6 months. Long term - meaning up to two years]
To compare astigmatism measured by keratometry
Astigmatism [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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.