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| Name | Class |
|---|---|
| South-Eastern Norway Regional Health Authority | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IOL repositioning group | Active Comparator |
| |
| IOL exchange group | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IOL repositioning | Procedure | Intraocular lens repositioning by scleral suturing |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammation in the anterior chamber after surgery | Measured with a Laser Flare Meter | The first weeks after surgery |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Best Corrected Visual acuity (BCVA) | Measured in Snellen |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marius Dalby, M.D. PhD Cand. | Contact | +47 92408957 | marius.dalby@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Liv Drolsum, Prof. M.D. PhD | Oslo University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital | Recruiting | Oslo | Norway |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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Randomized clinical trial
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Masking of research optometrists to group affiliation at the postoperative examinations will be endeavored. A physician will perform slit lamp examinations at the postoperative visits, hence he/she cannot be masked, nor can the surgeon. The investigator will be masked during the image analysis.
| IOL exchange |
| Procedure |
Intraocular lens exchange with retropupillary iris-claw lens |
|
| Short term (the first weeks and up to 6 months) and long term (up to two years) |
| Glare | Measured by straylight meter | Medium term (6 months) |
| Glare | Measured by subjective presence of glare | Medium term (6 months) |
| Endothelial cells | Measured by Non-contact corneal confocal microscopy | Short term (2 weeks) and long term (6months and 2 years) |
| 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) |
| IOL tilt | Measured with anterior segment Ultra Sound | 6 months and 2 years |
| IOL tilt | Measured with Anterior segment optical coherence tomography | 6 months and 2 years |
| 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 |
| 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 |
| Astigmatism | To compare astigmatism measured by keratometry | Short term - meaning 2 weeks to 6 months. Long term - meaning up to two years |
| 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 |