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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 70
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
United Kingdom
London Vision Clinic
RECRUITING
London
Contact Information
Primary
Timothy J Archer, PhD
tim@londonvisionclinic.com
02072241005
Time Frame
Start Date: 2019-08-01
Estimated Completion Date: 2027-11-01
Participants
Target number of participants: 65
Treatments
Other: Observational Phase 1
A trans-epithelial PTK procedure will be performed using the MEL 90 excimer laser. The refractive outcome will be compared to the refractive change predicted by the EpiMaster application software. Data is collected prospectively.
Other: Observational Phase 1b
A trans-epithelial PTK procedure will be performed using the MEL 90 excimer laser. The refractive outcome will be compared to the refractive change predicted by the EpiMaster application software. Data is collected retrospectively.
Experimental: Treatment Phase 2
If the transition criteria are met during the observational phase, the treatment phase will be initiated. A trans-epithelial PTK procedure will be performed using the MEL 90 excimer laser, including a refractive component according to the values determined using the EpiMaster application software.
Related Therapeutic Areas
Sponsors
Leads: London Vision Clinic
Collaborators: Optana GmbH

This content was sourced from clinicaltrials.gov