Treatment of Vision Disturbances Due to Corneal Irregularities by Trans-epithelial Optical Phototherapeutic Keratectomy (TE-oPTK)

Launched by LONDON VISION CLINIC · Feb 14, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a new method called trans-epithelial phototherapeutic keratectomy (TE-PTK) to help improve vision for people with a condition known as irregular astigmatism, which can cause blurry or distorted vision. The researchers are testing a software called EpiMaster that aims to predict how much a person's vision might improve after the procedure. If the software proves to be accurate, it will help doctors plan better treatments for patients undergoing TE-PTK.

To be eligible for this trial, participants must be at least 21 years old and have specific vision issues related to irregular astigmatism that make TE-PTK a suitable treatment option. They should also be medically fit for laser eye surgery and meet certain requirements regarding their eye health and thickness of the cornea. Participants in the trial will undergo evaluations and follow-up visits to monitor their progress. It's important to note that some people, such as those with autoimmune diseases or certain eye conditions, may not be eligible to join. If you're considering this trial, you'll need to stop wearing contact lenses for a short time before the study begins and be ready to sign an informed consent form to participate.

Gender

ALL

Eligibility criteria

• 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
• • Infection
• • Any residual, recurrent, or active abnormality of the cornea to be treated, e.g.
• • Existing corneal implant
• • Corneal lesion
• • Unstable refraction
• • Connective tissue disease
• • Dry eye