Status:
UNKNOWN
Late In-the-bag intraOcular Lens dislocatioN Surgery
Lead Sponsor:
Oslo University Hospital
Collaborating Sponsors:
South-Eastern Norway Regional Health Authority
Conditions:
Intraocular Lens Dislocation
Eligibility:
All Genders
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 9 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03276104
Start Date
September 9 2017
End Date
December 1 2022
Last Update
April 17 2019
Active Locations (1)
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1
Oslo University Hospital
Oslo, Norway