Late In-the-bag intraOcular Lens dislocatioN Surgery

Not Applicable

• Conditions: Intraocular Lens Dislocation
• Interventions: Procedure: IOL exchange; Procedure: IOL repositioning

• Registration Number: NCT03276104
• Lead Sponsor: Oslo University Hospital

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.

Study Timeline

• Study First Submitted: 2017-08-31
• Study First Submitted QC: 2017-09-05
• Study First Posted: 2017-09-08
• Study Start: 2017-09-09
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-16
• Last Update Posted: 2019-04-17
• Primary Completion: 2020-11
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IOL exchange group	IOL exchange	-
IOL repositioning group	IOL repositioning	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Glare	Medium term (6 months)	Measured by subjective presence of glare
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 determine whether suture placement for IOL repositioning affects the refractive outcome
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
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
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

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway