Health Condition 1: null- Low Myopia Health Condition 2: H521- Myopia
Conditions
Interventions
Intervention1: no treatment: nil
Control Intervention1: Photorefractive intrastromal crosslinking (PiXL): It has been proposed that corneal cross-linking performed using specific dose patterning (PiXL
Sponsors
Avedro Inc
Eligibility
Inclusion criteria
Inclusion criteria: 1.Provide written informed consent; 2.Willingness and ability to follow all instructions and comply with schedule for follow-up visits; 3.Having BSCVA of 20/32 or better; 4. Having manifest myopic refractive error of -0.75 D to -4.0 D, with refractive cylinder 5. Contact Lens Wearers Only: Discontinue use of contact lenses according to the table below, prior to the preoperative examination, and through the day of surgery; All contact lens wearers must demonstrate a stable refraction (within ±0.5 D), as determined by MRSE, on two consecutive examinations at least 1 week apart, in the eye to be treated
Exclusion criteria
Exclusion criteria: 1. A known allergy to the test article(s) or their components; 2. Corneal pachymetry that is measured by Pentacam in the eye to be treated; 3. Previous ocular condition (other than refractive error) in the eye to be treated that may predispose the eye for future complications. For example: a. History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.) b. Clinically significant corneal scarring in the cross-linking treatment zone that in the investigatorâ??s opinion, will interfere with the cross-linking procedure; c. A history of chemical injury or delayed epithelial healing in the eye(s) to be treated; 4. Pregnancy (including plans to become pregnant) or lactation during the course of the study; 5. Patients with nystagmus or any other condition that would prevent a steady gaze during the treatment or other diagnostic tests; 6. Patients with a current condition that, in the investigatorâ??s opinion, would interfere with or prolong epithelial healing; 7. A history of previous intra-ocular surgery or previous corneal surgery (including refractive surgical procedures) in the eye to be treated.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy Evaluations: Mean change in manifest refraction (MR) and manifest refraction spherical equivalent (MRSE) from baseline. ï?· Mean change in unaided visual acuity (UCVA) from baseline ï?· Mean change in corneal curvature (as measured by Kmean, K Flat, and K Steep) from baseline.Timepoint: 1 day, 1 week, 1, 3, 6 and 12 months after PiXL treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Evaluations: ï?· Best Corrected Visual Acuity ï?· Slit lamp biomicroscopy ï?· Endothelial Cell Count (specular microscopy) ï?· Adverse eventsTimepoint: 1 day, 1 week, 1, 3, 6 and 12 months after PiXL treatment | — |
Countries
Germany, India, Singapore
Contacts
Public ContactDr Ritika Sachdev
Centre for Sight Hospital
Outcome results
None listed