A clinical study on laser visual correction using investigational device Elita, to be conducted in multiple clinical trial sites.

Phase 3

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

• Registration Number: CTRI/2022/10/046292
• Lead Sponsor: Johnson 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: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. A residual anticipated stromal bed thickness of at least 250 microns 2. Subjects with myopia or hyperopia with or without astigmatism (including mixed astigmatism) eligible for commercial LASIK treatment. 3. Pre-op distance Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better 4.Pre-op distance Uncorrected Visual Acuity (UCVA) of 20/32 or worse 5. Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment. 6. Willing and capable of complying with follow-up examinations for the duration of the study.

Exclusion Criteria

1. Concurrent use of systemic (including inhaled) medications that may impair healing,

including but not limited to: antimetabolites, isotretinoin (Accutane�®) within 6 months

of treatment, and amiodarone hydrochloride (Cordarone�®) within 12 months of

treatment.

2. History of any of the following medical conditions, or any other condition that could

affect wound healing: collagen vascular disease, autoimmune disease,

immunodeficiency diseases, ocular herpes zoster or herpes simplex, endocrine

disorders (including, but not limited to unstable thyroid disorders and diabetes),

lupus, and rheumatoid arthritis.

Subjects with a cardiac pacemaker, implanted defibrillator or other implanted

electronic device.

3. History of prior intraocular or corneal surgery (including cataract extraction), active

ophthalmic disease or abnormality (including, but not limited to, symptomatic

blepharitis/conjunctivitis, recurrent corneal erosion, dry eye syndrome,

neovascularization > 1 mm from limbus), retinal detachment/repair, clinically

significant lens opacity, clinical evidence of trauma, corneal opacity within the central

9 mm and visible on topography, at risk for developing strabismus, or with evidence

of glaucoma or propensity for narrow angle glaucoma.

4. Evidence of keratoconus, corneal dystrophy or irregularity, corneal edema, corneal

lesion, hypotony, or abnormal topography.

5. Known sensitivity or inappropriate responsiveness to any of the medications used in

the postoperative course.

6. A fellow eye that does not meet all inclusion criteria and does not fall within approved

indications for treatment using excimer Laser.

7. Desire for monovision correction

8.Women who are pregnant, breast-feeding, or intend to become pregnant during the

course of the study.

9. Participation in any other clinical study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint for the study is the ease of flap lift, as measured by the proportion of eyes where a clinically acceptable flap lift was created. Clinically acceptable flap lift is defined as a score of 0-2 on the ease of flap lift questionnaire item. <br/ ><br>Success criteria: the ease of flap lift should be graded 0-2 in at least 90% eyesTimepoint: Operative visit.