Feasibility Study of Laser Treatment of the Crystalline Lens to Correct Presbyopia (NCT01062412) | Clinical Trial Compass
TerminatedNot Applicable
Feasibility Study of Laser Treatment of the Crystalline Lens to Correct Presbyopia
Stopped: No improvement in near vision was detected
Philippines80 participantsStarted 2009-12
Plain-language summary
The study will evaluate whether the LensAR laser system can be used in the lens of the eye to increase the ability to read and/or see near objects
Who can participate
Age range45 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subjects must sign and be given a copy of the written informed consent form.
* Subjects must have elected to undergo lens extraction and IOL implantation to treat their ocular disorder then elect to have the LensAR laser surgery as part of the procedure.
* Cataract should not exceed LOCS III Grade 2.
* Subjects must have best corrected distance visual acuity of 20/40 or better in the eye to be treated .
* Subjects must be ≥ 45 years and ≤ 60 years of age at time of subject eligibility visit.
* Subjects must be willing and able to return for scheduled follow up examinations for 6 months after cataract surgery or up to 3 years (at 6 month intervals) if no cataract surgery is performed.
* Subject must have central 7 mm of clear cornea without vascularization
Exclusion Criteria:
* Subjects who are pregnant, lactating, or planning to become pregnant during the course of the study.
* Subjects who have undergone previous corneal or intraocular surgery in the eye to be treated.
* Subjects with a history, signs or symptoms of ocular disease or atypical finding which would be contraindicated under standard of care for cataract surgery.
* Diabetic or hypertensive subjects with clinical evidence of retinal pathology.
* Subjects with macular degenerative pathology.
* Subjects with a history of steroid-responsive rise in IOP or uncontrolled glaucoma in either eye.
* Subjects with known lens/zonular instability such as, but not restricted to, Marfan's Syndrome, Pseu…