Treatment for vision problems caused by corneal irregularities using a laser procedure
Treatment of Vision Disturbances Due to Corneal Irregularities by Trans-epithelial Optical Phototherapeutic Keratectomy (TE-oPTK)
This study is testing a new software to see if it can help doctors better plan a laser treatment for people with vision problems caused by irregular corneas.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 65 (estimated) |
| Ages | 21 Years to 70 Years |
| Sex | All |
| Sponsor | London Vision Clinic Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT03841253 on ClinicalTrials.gov |
What this trial studies
This study evaluates the EpiMaster application software to predict refractive changes after a trans-epithelial phototherapeutic keratectomy (TE-PTK) procedure for patients with irregular astigmatism. The goal is to validate the software's predictive capabilities during an observational phase, which will then guide the planning of TE-PTK treatments. The procedure aims to improve visual symptoms caused by corneal irregularities by using a laser to reshape the cornea effectively. This approach is particularly beneficial for patients whose irregularities are not adequately addressed by traditional topography-guided ablation.
Who should consider this trial
Good fit: Ideal candidates are patients with irregularly irregular astigmatism and associated vision quality issues who are medically suitable for corneal laser refractive surgery.
Not a fit: Patients with autoimmune diseases, dry eye conditions, or those unable to tolerate local anesthesia may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve vision quality for patients suffering from corneal irregularities.
How similar studies have performed: Other studies have shown success with similar laser treatments for corneal irregularities, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
London
- London Vision Clinic — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Timothy J Archer, PhD
- Email: tim@londonvisionclinic.com
- Phone: 02072241005
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.