Status:
RECRUITING
Treatment of Vision Disturbances Due to Corneal Irregularities by Trans-epithelial Optical Phototherapeutic Keratectomy (TE-oPTK)
Lead Sponsor:
London Vision Clinic
Collaborating Sponsors:
Optana GmbH
Conditions:
Corneal Astigmatism
Eligibility:
All Genders
21-70 years
Phase:
NA
Brief 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 wit...
Detailed Description
Complications after laser eye surgery can often result in the front surface of the eye (the cornea) becoming irregular, which causes visual symptoms such as halos, glare, starbursts, double vision, an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2027
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT03841253
Start Date
August 1 2019
End Date
November 1 2027
Last Update
March 5 2025
Active Locations (1)
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1
London Vision Clinic
London, United Kingdom, W1G 7LA