Inclusion Criteria Clinical Trial
Official title:
Implantation of Add on Lens for Age Related Macular Degeneration Patients With Low Vision
Age related macular degeneration (AMD) is the leading cause of vision loss in patients older
than 55 years old. AMD can present as dry AMD or wet AMD. In most cases AMD affects both
eyes although in many cases it's asymmetrical as far as severity. Some patients require low
vision aids to continue their daily life tasks. In the past a few attempts were made to use
low vision intraocular lenses with corrective glasses without enough success. In addition
telescopic and prismatic lenses were also tried. The difficulties with these lenses included
low field of vision, unsatisfactory magnification, complicated surgical technique and high
complication rates.
Recently an add on lens was designed for the sulcus for implantation in pseudophakic AMD
patients. The add on lens doubles the magnification of the central image dependent on the
reading distance and the anatomy of the eye.
The lens is acrylic hydrophobic and designed for implantation in the sulcus either in
pseudophakic patients or in addition to an intraocular lens implanted during a routine
cataract surgery. The lens is 13 mm wide with 4 symmetric haptics. The lens has 1.5 mm
central part of 10 diopters and the rest of the lens has no optical power.
Our purpose is to study implantation of the lenses in AMD patients to improve their reading
ability and to improve their daily living.
Study design Prospective study on implantation of the add on lenses in AMD patients. The
study was approved by Rabin medical center IRB.
Patients will be examined for best corrected visual acuity prior to the surgery at 6 meter
and for reading at 40 and 15 cm. Improvement of the reading ability at 15 cm compared to 40
cm will predict the potential for vision improvement with the add on lens.
Before the surgery patients will have a full ophthalmological examination. Patients will
have axial length and keratometry examination using the biometry. The lens will be implanted
in surgery through a 2.2 mm clear cornea and will be injected and positioned in the sulcus.
Patients will be followed up at 1 day, 1 week, 4 weeks, 4 and 6 months following surgery.
During follow up patients will undergo full ophthalmic exam and well as visual acuity both
for distance and near.
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