EVALUATION OF AN ADVANCED LASER SYSTEM TO HELP MAKE SPECTACLE REMOVAL SURGERY SAFER AND FASTER

Not Applicable

• Conditions: Health Condition 1: H522- AstigmatismHealth Condition 2: H520- HypermetropiaHealth Condition 3: H521- Myopia

• Registration Number: CTRI/2018/12/016733
• Lead Sponsor: JOHNSON AND JOHNSON SURGICAL VISION INC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Phase I of study

To be considered for enrollment in phase I of the study, subject must:

1. Sign an informed consent and HIPAA authorization

2. Be at least 18 years of age at the time of study exam

3. Have best corrected vision of 20/50 or worse

4. Be available for all scheduled follow-up visits

Phase II of study

To be considered for enrollment in phase II of the study, subject must:

1. Sign an informed consent and HIPAA authorization

2. Be at least 18 years of age at the time of study exam

3. Have refractive error and be eligible for commercial LASIK treatment

4. Be available for all scheduled follow-up visits

Exclusion Criteria

Subject will not be eligible to take part in phase I of the study if subject, use or have:

� Known to be pregnant, breastfeeding or intend to become pregnant during the study.

� Recent ocular (eye) trauma or eye surgery

� A history of or active ophthalmic (eye) disease or abnormality

� Ocular hypertension (high eye pressure) with IOP (eye pressure) greater than 21 mmHg, glaucoma suspect, or are taking medications for these conditions

� A history or current diagnosis of any of the following medical conditions that could affect wound healing: collagen vascular disease, autoimmune disease, immunodeficiency disease, ocular herpes; endocrine disorders including, but not limited to unstable thyroid disorders and diabetes, lupus, and rheumatoid arthritis.

� Cardiac pacemaker, implanted defibrillator or other implanted electronic device

� Taking systemic or inhaled medications that may affect wound healing

� Known sensitivity or inappropriate responsiveness to any of the medications used in the study

� Participating in any other clinical study

Subject will not be eligible to take part in phase II of the study if subject, use or have:

� Known to be pregnant, breastfeeding or intend to become pregnant during the study.

� Recent ocular (eye) trauma or eye surgery

� A history of or active ophthalmic (eye) disease or abnormality

� Ocular hypertension (high eye pressure) with IOP (eye pressure) greater than 21 mmHg, glaucoma suspect, or are taking medications for these conditions

� A history or current diagnosis of any of the following medical conditions that could affect wound healing: collagen vascular disease, autoimmune disease, immunodeficiency disease, ocular herpes; endocrine disorders including, but not limited to unstable thyroid disorders and diabetes, lupus, and rheumatoid arthritis.

� Cardiac pacemaker, implanted defibrillator or other implanted electronic device

� Taking systemic or inhaled medications that may affect wound healing

� Known sensitivity or inappropriate responsiveness to any of the medications used in the study

� Desire for monovision correction

� Participating in any other clinical study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cheetah ease of flap lift, surface quality, and amount of opaque bubble layer (OBL) will <br/ ><br>be graded on a scale of 1-5 relative to IntraLase iFS flap. A score of 3 means that <br/ ><br>Cheetah is similar to iFS; a score of 4 or 5 means that Cheetah is superior to iFS; and a <br/ ><br>score of 1 or 2 means that iFS is superior to Cheetah. 90% of all subjects are expected <br/ ><br>to have a score equal to or greater than 3 for each of the evaluations <br/ ><br>Timepoint: 1 DAY POST OPERATIVE <br/ ><br>1 WEEK POST OPERATIVE <br/ ><br>1 MONTH POST OPERATIVE <br/ ><br>3 MONTHS POST OPERATIVE

Secondary Outcome Measures

Name	Time	Method
CHEETAH WORKFLOW FLAP CREATION <br/ ><br>SPEED OF PROCEDURE <br/ ><br>SUCTION LOSSES <br/ ><br>PACHYMETRY MEASUREMENTS <br/ ><br>OPTICAL COHERENCE TOMOGRAPHY(OCT) <br/ ><br>BSCVA(BEST SPECTACLE CORRECTED VISUAL ACUITY) <br/ ><br>UCVA(UN CORRECTED VISUAL ACUITY) <br/ ><br>MRSE(MANIFEST REFRACTIVE SPHERICAL EQUIVALENT) <br/ ><br>Timepoint: 1 DAY POST OP, <br/ ><br>1 WEEK POST OP, <br/ ><br>1 MONTH POST OP, <br/ ><br>3 MONTHS POST OP