Corneal Refractive Therapy Design Comparison for -4 to -6 Diopter Treatment for Overnight Wear fo… (NCT05438615) | Clinical Trial Compass
CompletedNot Applicable
Corneal Refractive Therapy Design Comparison for -4 to -6 Diopter Treatment for Overnight Wear for Myopia
United States40 participantsStarted 2015-12
Plain-language summary
The primary objective of this study is to compare the effectiveness of two proximity control geometry lens designs to treat eyes with pretreatment myopia between -4.00 and -6.00 D myopia with and without refractive astigmatism in a modality involving overnight wearing.
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
. Patients may be male or female, of any race, and at least 18 years old at the time of the pre-treatment examination.
. The prospective eye(s) must have naturally occurring refractive myopia from -4.00 to -6.00 diopters sphere (spectacle plane), with up to -1.75 diopters of refractive astigmatism (spectacle plane), as determined by manifest refraction (phoropter or trial frame with a 12.5 mm vertex distance).
. Patients must have best spectacle corrected visual acuity of at least 0.04 logMAR in each eye.
. If the Subject wears rigid contact lenses in the prospective eye(s), lens use must cease at least four (4) weeks prior to the pre-treatment examination. The subject must have two central keratometry readings taken that are at least one week apart. The two readings shall not differ by more than 0.50 diopter in either meridian. The mires should be regular.
. Patients must be willing and capable to return for all scheduled follow-up visits for a period of at least 6 months.
Exclusion criteria
. Female patients who are pregnant, breast-feeding or intend to become pregnant over the course of the study.
. Patients with a history of any of the following medical conditions: collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or simplex, endocrine disorders (including, but not limited to active thyroid disorders and diabetes), lupus, and rheumatoid arthritis.
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
Refraction
Timeframe: Two weeks after successful fitting of each lens
2
visual acuity
Timeframe: Two weeks after successful fitting of each lens
. Patients with a history of intraocular or corneal surgery (including cataract extraction), active ophthalmic disease or abnormality (including, but not limited to, blepharitis, recurrent corneal erosion, dry eye syndrome, neovascularization \>1mm from limbus), clinically significant lens opacity, clinical evidence of trauma (including scarring).
. Patients with evidence of keratoconus, corneal irregularity, or abnormal videokeratography in either eye.
. Patients with pupil size greater than 5.5 mm in photopic illumination as measured with infrared pupillometry, pupil detection component of computer assisted video keratography, or slit lamp reticule.
. Patients who are participating in any other clinical trial (FDA or other).