Clinical trial NCT03276104: Late In-the-bag intraOcular Lens dislocatioN Surgery
Official title: Late In-the-bag intraOcular Lens dislocatioN Surgery: A Randomized Clinical Trial (LION Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intraocular Lens Dislocation
Keywords: IOL dislocation
Cataract
Cataract surgery
Scleral suturing
Verisyse
Iris-claw
Late in-the-bag IOL dislocation
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: South-Eastern Norway Regional Health Authority
First posted: 2017-09-08
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Inflammation in the anterior chamber after surgery
timeFrame: The first weeks after surgery
measure: Changes in macular thickness and occurrence of Cystoid macular edema
timeFrame: The first months after surgery, and long term changes months up to two years after surgery
measure: Intraocular pressure changes
timeFrame: Early changes in the first weeks after surgery, and long term changes months up to two years after surgery
Secondary outcomes:
measure: Best Corrected Visual acuity (BCVA)
timeFrame: Short term (the first weeks and up to 6 months) and long term (up to two years)
measure: Best Corrected Visual acuity (BCVA)
timeFrame: Short term (the first weeks and up to 6 months) and long term (up to two years)
measure: Glare
timeFrame: Medium term (6 months)
measure: Glare
timeFrame: Medium term (6 months)
measure: Endothelial cells
timeFrame: Short term (2 weeks) and long term (6months and 2 years)
measure: Intra- and postoperative complications
timeFrame: Short term and long term (first post operative day, the first weeks and months, and up to two years)
measure: IOL tilt
timeFrame: 6 months and 2 years
measure: IOL tilt
timeFrame: 6 months and 2 years
measure: Refractive outcomes - subjective refraction measured with a phoropter
timeFrame: Short term - meaning 2 weeks to 6 months. Long term - meaning up to two years
measure: Refractive outcomes - subjective refraction measured with a phoropter
timeFrame: Short term - meaning 2 weeks to 6 months. Long term - meaning up to two years
measure: Astigmatism
timeFrame: Short term - meaning 2 weeks to 6 months. Long term - meaning up to two years
measure: Astigmatism
timeFrame: Short term - meaning 2 weeks to 6 months. Long term - meaning up to two years
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Liv Drolsum, Prof. M.D. PhD
role: STUDY_CHAIR
References: