Evaluation of a non-surgical treatment for low myopia

Not Applicable

• Conditions: Health Condition 1: null- Low MyopiaHealth Condition 2: H521- Myopia

• Registration Number: CTRI/2017/11/010331
• Lead Sponsor: Avedro Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

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 <=0.50 D, with stable refractive error for 12 months as demonstrated by a change of <= 0.50 D MRSE.

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

1. A known allergy to the test article(s) or their components;

2. Corneal pachymetry that is < 475 microns at the thinnest point

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy Evaluations: <br/ ><br>Mean change in manifest refraction (MR) and manifest refraction spherical equivalent (MRSE) from baseline. <br/ ><br>ï?· Mean change in unaided visual acuity (UCVA) from baseline <br/ ><br>ï?· Mean change in corneal curvature (as measured by Kmean, K Flat, <br/ ><br>and K Steep) from baseline.Timepoint: 1 day, 1 week, 1, 3, 6 and 12 months after PiXL treatment

Secondary Outcome Measures

Name	Time	Method
Safety Evaluations: <br/ ><br>ï?· Best Corrected Visual Acuity <br/ ><br>ï?· Slit lamp biomicroscopy <br/ ><br>ï?· Endothelial Cell Count (specular microscopy) <br/ ><br>ï?· Adverse eventsTimepoint: 1 day, 1 week, 1, 3, 6 and 12 months after PiXL treatment