se of a new laser technique (SMILE - Small Incision lenticular extraction) to remove glasses for both near and distance visio
- Conditions
- Health Condition 1: H521- Myopia
- Registration Number
- CTRI/2019/07/020437
- Lead Sponsor
- Carl ZEISS India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Age >=40 yearsâ?¨
2. Myopia 1.0D to 10 D â?¨
3. Refractive cylinder -4.00 DCL or less. â?¨
4. Best spectacle corrected visual acuity (BSCVA) of 6/9 or better in each eye â?¨
5. Stable refraction with less than -0.50D spherical or cylindrical error change in last one year.â?¨
6. Contact lens wearers must have removed contact lenses at least two (2) weeks before the baseline measurement.
7. No evidence of irregular astigmatism on corneal topography. â?¨
8. Available to attend post-operative examinations for a 12-month period.
9. Near Add > 0DSâ?¨
1. Progressive or unstable myopia and/or astigmatism.â?¨
2. Clinical or corneal topographic evidence of keratoconus.â?¨
3. A residual stromal bed thickness that is less than 275 microns from the corneal endothelium.
4. Residual, recurrent or active ocular disease such as uveitis, severe dry eyes, severe allergic eye disease, glaucoma, visually significant cataract andâ?¨retinal disease.â?¨
5. Previous corneal surgery or trauma.â?¨
6. Taking systemic medications likely to affect wound healing, such as corticosteroids and antimetabolites.â?¨
7. Systemically immunocompromised.â?¨
8. Systemic disease likely to affect wound healing, such as diabetes, connective tissue disease and severe atopy.â?¨
9.Pregnant or nursing.
10. Use of Prisms
11. Manifest Squint
12.History of Corrected Strabismus
13.Subnormal stereoacuity ( >60 Seconds of Arc)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method