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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
Intraocular lens repositioning by scleral suturing
Intraocular lens exchange with retropupillary iris-claw lens
Oslo University Hospital
Oslo, Norway
RECRUITINGInflammation in the anterior chamber after surgery
Measured with a Laser Flare Meter
Time frame: The first weeks after surgery
Changes in macular thickness and occurrence of Cystoid macular edema
Evaluated with Optical Coherence Tomography
Time frame: 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
Time frame: Early changes in the first weeks after surgery, and long term changes months up to two years after surgery
Best Corrected Visual acuity (BCVA)
Measured in LogMar
Time frame: 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
Time frame: Short term (the first weeks and up to 6 months) and long term (up to two years)
Glare
Measured by straylight meter
Time frame: Medium term (6 months)
Glare
Measured by subjective presence of glare
Time frame: Medium term (6 months)
Endothelial cells
Measured by Non-contact corneal confocal microscopy
Time frame: Short term (2 weeks) and long term (6months and 2 years)
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Intra- and postoperative complications
All relevant complications
Time frame: 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
Time frame: 6 months and 2 years
IOL tilt
Measured with Anterior segment optical coherence tomography
Time frame: 6 months and 2 years
Refractive outcomes - subjective refraction measured with a phoropter
To compare the refractive outcomes (short and long-term)
Time frame: 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
Time frame: Short term - meaning 2 weeks to 6 months. Long term - meaning up to two years
Astigmatism
To compare astigmatism measured by keratometry
Time frame: 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
Time frame: Short term - meaning 2 weeks to 6 months. Long term - meaning up to two years