Laser Treatment of the Crystalline Lens (NCT01001117) | Clinical Trial Compass
UnknownPhase 2/3
Laser Treatment of the Crystalline Lens
Mexico75 participantsStarted 2008-10
Plain-language summary
The use of a femtosecond laser in cataract surgery that gives equivalent or improved results comapred to conventional phaco-emulsification surgery.
Who can participate
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 foldable monofocal IOL implantation (ideally of the same type), and then elect to have the LensAR laser surgery.
* Subjects must be willing and able to return for scheduled follow-up examinations for a minimum of 12 months after surgery.
* Central 8 mm of clear cornea without vascularization.
Exclusion Criteria:
* Subjects with prior anterior segment or vitreo-retinal surgical intervention in the eye to be treated.
* Subjects with lenticular cataracts with nuclear grading greater than Grade 4 on the LOCS III scale.
* Subjects who cannot attain ocular dilation of 7.0 mm.
* Subjects with anterior segment pathology in the eye to be treated that is not directly improved by lens extraction and IOL implantation.
* Subjects with residual, recurrent, active ocular or uncontrolled eyelid disease or any corneal abnormalities (including endothelial dystrophy, guttata, recurrent corneal erosion, etc.) in the eye to be treated.
* Subjects with ophthalmoscopic signs of keratoconus (or keratoconus suspect) in the eye to be treated.
* Subjects with a history of severe dry eye not responding to therapy.
* Subjects with macular degeneration, history of retinal detachment, or any other fundus findings that would pose a risk to safety or an acceptable visual outcome in the eye to be treated.
* Subjects with a history of herpes zoster or…
What they're measuring
1
Capsulotomy a. Ease of opening b. Achievement of intended shape and size
Timeframe: Time of Surgery
2
Lens removal a. Ease of irrigation / aspiration (time) b. Reduced ultrasound phacoemulsification
Timeframe: Time of surgery
3
Posterior capsule rupture < 10% occurrence rate
Timeframe: Time of Surgery
4
Less than 5% of eyes should lose more than two lines of BSCVA