Late In-the-bag intraOcular Lens dislocatioN Surgery (NCT03276104) | Clinical Trial Compass
UnknownNot Applicable
Late In-the-bag intraOcular Lens dislocatioN Surgery
Norway50 participantsStarted 2017-09-09
Plain-language 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.
Who can participate
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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 excl…
What they're measuring
1
Inflammation in the anterior chamber after surgery
Timeframe: The first weeks after surgery
2
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
3
Intraocular pressure changes
Timeframe: Early changes in the first weeks after surgery, and long term changes months up to two years after surgery