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 range21 Years – 70 Years
SexALL
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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…
What they're measuring
1
The tendency of manifest sphere, cylinder and axis