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
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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