Study of the MEL 80 Excimer Laser Using LASIK in the Treatment of Moderate to High Myopia (NCT00762541) | Clinical Trial Compass
CompletedNot Applicable
Study of the MEL 80 Excimer Laser Using LASIK in the Treatment of Moderate to High Myopia
United States129 participantsStarted 2006-10
Plain-language summary
The purpose of this study is to determine whether the MEL 80 Excimer Laser is effective in the treatment of moderate to high myopia (nearsightedness), when used as part of the Laser In Situ Keratomileusis (LASIK) procedure.
Who can participate
Age range
18 Years
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:
* Myopia \> -7.00 D to -12.00 D, and astigmatism less than or equal to -6.00 D at the spectacle plane, with a maximum MRSE ≤-12.00 D.
* Stable refraction for at least the last twelve months, as demonstrated by a change of less than 1.00 D of the spherical equivalent during the twelve months prior to the baseline examination of the eye to be treated, documented by previous clinical records.
* Discontinue use of contact lenses at least 2 weeks for hard contacts and 3 days for soft lenses prior to the preoperative examination.
* Hard contact lens wearers must have two central keratometry readings and two manifest refractions taken at least one week apart that do not differ by more than 0.50 D.
* Visual acuity correctable to at least 20/40 in both eyes.
* UCVA of 20/40 or worse in the operative eye.
* At least 18 years of age.
* Operative eye must be targeted for emmetropia.
* Have a normal corneal topography.
* Willing and able to return for scheduled follow up examinations for twelve months after surgery.
* Sign and be given a copy of the written Informed Consent form.
Exclusion Criteria:
* History of anterior segment pathology, including cataracts (in the operative eye).
* Clinically significant dry eye syndrome unresolved by treatment.
* Residual, recurrent, active ocular or uncontrolled eyelid disease, corneal scars within the ablation zone or other corneal abnormality such as recurrent corneal erosion or severe basement membrane disease.
* Ophthalmosc…
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
At the point of stability, for myopes > 7 D spherical equivalent (SE), a minimum of 30% should have an achieved refraction within ± 0.50 D of the intended outcome, and 60% should have an achieved refraction within ± 1.00 D of the intended outcome.
Timeframe: Point of stability
2
For myopes > 7 D spherical equivalent (SE), a minimum of 75% of eyes should have an uncorrected visual acuity of 20/40 or better at the postoperative interval at which stability has been established.
Timeframe: Point of stability
3
95% of eyes should have a change of < 1.00 D in manifest refraction spherical equivalent (MRSE) between 2 refractions performed at least 3 months apart, and the mean rate of MRSE change per month should be < 0.04 D.
Timeframe: Point of stability
4
Distance BSCVA of worse than 20/40 at the postoperative interval at which stability has been established should occur in less than 1% of eyes that had a BSCVA of 20/20 or better before surgery.
Timeframe: Point of stability
5
Loss of more than 2 lines of BSCVA should occur in less than 5% of eyes
Timeframe: Point of stability
6
Less than 5% of eyes treated for sphere only should have a magnitude of postoperative manifest refractive astigmatism that varies from baseline cylinder by greater than 2.00 D at the postoperative interval at which stability has been established.