Treatment of Vision Disturbances Due to Corneal Irregularities by Trans-epithelial Optical Photot… (NCT03841253) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Treatment of Vision Disturbances Due to Corneal Irregularities by Trans-epithelial Optical Phototherapeutic Keratectomy (TE-oPTK)
United Kingdom45 participantsStarted 2019-08-01
Plain-language summary
This study sets out to evaluate the EpiMaster application software for use in predicting the refractive change induced by a trans-epithelial phototherapeutic keratectomy (TE-PTK) procedure in eyes with irregularly irregular astigmatism. If validation criteria are met during the observational phase, the software refractive prediction will be used to plan the refractive correction in TE-PTK treatments.
Who can participate
Age range
21 Years – 70 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:
* Patient presents with topographic irregularly irregular astigmatism and associated quality of vision issues, where TE-PTK would be a more effective treatment than topography-guided ablation or other therapeutic treatment options.
Medically suitable for corneal laser refractive surgery.
* Calculated residual stromal thickness ≥250 µm.
* Subjects should be 21 years of age or older.
* Contact lens wearers must stop wearing their contact lenses one week per decade of wear before baseline measurements in case of hard contact lenses and one week before baseline measurements in case of soft contact lenses.
* Patient will be able to understand the patient information and willing to sign an informed consent.
* Patient will be willing to comply with all follow-up visits and the respective examinations.
Exclusion Criteria:
* Patient not being able to tolerate local or topical anesthesia
* Autoimmune diseases
* Sicca syndrome, dry eye
* Herpes viral (herpes simplex) infections
* Herpes zoster
* Diabetes
* Pregnant or nursing women (or who are planning pregnancy during the study)
* Patients with a weight of \> 135 kg
* Any residual, recurrent or acute ocular disease or abnormality of the eye, e.g.
* Cataract
* Suspected glaucoma or an intraocular pressure \> 21 mm of Hg
* Corneal disease
* Corneal thinning disorder, e.g. keratoconus,
* Pellucid marginal corneal degeneration
* Dystrophy of the basal membrane
* Corneal oedema
* Exudative macular degeneration
* Inf…
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
The tendency of manifest sphere, cylinder and axis