Late In-the-bag intraOcular Lens dislocatioN Surgery

Intraocular Lens Dislocation Clinical Trial

— LION  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03276104
• Other study ID #: 2017/5506
• Status: Recruiting
• Phase: N/A
• Start date: September 9, 2017
• Est. completion date: December 2022

Study information

• Verified date: April 2019
• Source: Oslo University Hospital
• Contact: Marius Dalby, M.D. PhD Cand.
• Phone: +47 92408957
• Email: marius.dalby[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2022
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Intraocular Lens Dislocation
• Lens Subluxation

Intervention

Procedure:
• IOL repositioning
Intraocular lens repositioning by scleral suturing
• IOL exchange
Intraocular lens exchange with retropupillary iris-claw lens

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	South-Eastern Norway Regional Health Authority

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammation in the anterior chamber after surgery	Measured with a Laser Flare Meter	The first weeks after surgery
Primary	Changes in macular thickness and occurrence of Cystoid macular edema	Evaluated with Optical Coherence Tomography	The first months after surgery, and long term changes months up to two years after surgery
Primary	Intraocular pressure changes	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	Best Corrected Visual acuity (BCVA)	Measured in LogMar	Short term (the first weeks and up to 6 months) and long term (up to two years)
Secondary	Best Corrected Visual acuity (BCVA)	Measured in Snellen	Short term (the first weeks and up to 6 months) and long term (up to two years)
Secondary	Glare	Measured by straylight meter	Medium term (6 months)
Secondary	Glare	Measured by subjective presence of glare	Medium term (6 months)
Secondary	Endothelial cells	Measured by Non-contact corneal confocal microscopy	Short term (2 weeks) and long term (6months and 2 years)
Secondary	Intra- and postoperative complications	All relevant complications	Short term and long term (first post operative day, the first weeks and months, and up to two years)
Secondary	IOL tilt	Measured with anterior segment Ultra Sound	6 months and 2 years
Secondary	IOL tilt	Measured with Anterior segment optical coherence tomography	6 months and 2 years
Secondary	Refractive outcomes - subjective refraction measured with a phoropter	To compare the refractive outcomes (short and long-term)	Short term - meaning 2 weeks to 6 months. Long term - meaning up to two years
Secondary	Refractive outcomes - subjective refraction measured with a phoropter	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
Secondary	Astigmatism	To compare astigmatism measured by keratometry	Short term - meaning 2 weeks to 6 months. Long term - meaning up to two years
Secondary	Astigmatism	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