Intraocular Lens Dislocation Clinical Trial
— LIONOfficial title:
Late In-the-bag intraOcular Lens dislocatioN Surgery: A Randomized Clinical Trial (LION Trial)
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.
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. |
Country | Name | City | State |
---|---|---|---|
Norway | Oslo University Hospital | Oslo |
Lead Sponsor | Collaborator |
---|---|
Oslo University Hospital | South-Eastern Norway Regional Health Authority |
Norway,
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 |
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