Health Condition 1: H521- Myopia
Conditions
Interventions
Intervention1: ReLex SMILE with ZEISS VisuMax: To perform SMILE monovision in eyes of patients having myopia along with presbyopia, desiring a spectacle free lifestyle.
Control Intervention1: NA: NA
Sponsors
Carl ZEISS India
Eligibility
Inclusion criteria
Inclusion criteria: 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?¨
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Uncorrected Visual acuity 2. Patient satisfaction in terms of independence from spectacles recorded in the form of a questionnaire. Timepoint: 1. At Day 1, Week 1, Month1,3 and 6 2. At Month 3 and6 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of eyes with â?¥ 2 lines BCVA loss. 2. Induced manifest refractive astigmatism â?? the percentage of eyes with induced manifest refractive cylinder 2.0 D at the final postoperative visit. 3. Incidence of adverse events â?? The counts and percentages of eyes for each adverse event. Timepoint: 1. At 1 month, 3, 6 months 2. at 1,3 and 6 months 3. At each follow up | — |
Countries
India
Contacts
Public ContactMahipal S Sachdev
Centre For Sight
Outcome results
None listed