Study of the MEL 80 Excimer Laser Using LASIK in the Treatment of Mixed Astigmatism (NCT00761826) | Clinical Trial Compass
CompletedNot Applicable
Study of the MEL 80 Excimer Laser Using LASIK in the Treatment of Mixed Astigmatism
United States126 participantsStarted 2007-01
Plain-language summary
The purpose of this study is to determine whether the MEL 80 Excimer Laser is effective in the treatment of mixed astigmatism up to 6.0 D, 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:
* Naturally occurring mixed astigmatism when the magnitude of cylinder (up to 6.0 D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs, at the spectacle plane;
* Have a stable refraction for at least the past twelve months, as demonstrated by a change of less than or equal to 0.50 D preoperative spherical equivalent shift over twelve months prior to surgery;
* 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
* Have visual acuity correctable to at least 20/40 in both eyes
* Have no more than 0.75 D of latent hyperopia as determined by the difference between the preoperative manifest refractive spherical equivalent (MRSE) and cycloplegic refractive spherical equivalent (CRSE);
* Be at least 18 years of age
* Corneal topography should be normal;
* The operative eye must be targeted for emmetropia;
* Be willing and able to return for scheduled follow-up examinations for twelve months after surgery;
* and provide written informed consent.
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 dis…
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, a minimum of 75% of eyes should have an achieved refraction within ± 1.00 D of the intended outcome, and at least 50% of eyes should be within ± 0.50 D of the intended outcome.
Timeframe: Point of stability
2
A minimum of 85% 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
A minimum of 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 1.0 % 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 5.0 % of eyes.
Timeframe: Postoperative visits
6
Incidence of adverse events to occur in less than 1% of eyes