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Comparative study of topography of corneal layers for refractive surgery planning

Customization of laser ablation profiles using Bowmanâ??s layer topography

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/03/008075
Enrollment
80
Registered
2017-03-14
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Patients willing to undergo refractive surgery to correct myopia and astigmatsim

Interventions

Intervention1: CONTURA laser-assisted in situ keratomileusis treatment: One eye will undergo laser-assisted in situ keratomileusis with CONTURA Topography guided system Control Intervention1: Bowmans

Sponsors

Narayana Nethralaya
Lead Sponsor
Alcon Laboratories Pvt Ltd
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients should be between 18 to 50 years of age. 2. Patient must have stable myopia for a minimum period of one year (a change of 0.25D or less) as documented by prior clinical records or current spectacle correction. Patient must have a corrected distance visual acuity of 0.8 Decimal or better, 3. Patient must have a spherical equivalent refraction less than -10D 4. Patient must have refractive astigmatism less than -3D.

Exclusion criteria

Exclusion criteria: 1. Patient must not have a central corneal thickness less than 480 micrometer 2.Patient must not have a calculated residual s stromal bed thickness of less than 250 micrometer after the surgery 3. Patient must not have symptoms or signs of keratoconus, diabetes, collagen vascular disease, pregnancy, breastfeeding and any prior ocular surgery. 4. Patient must not have an inter-ocular difference of more than 1.00 diopter of spherical or 0.50 D of cylindrical refractive error. 5. Patient must not be on chronic systemic steroids or other medication that can affect wound healing. 6. Patient must not be allergic to primary or alternative medications. 7. Patient must not be using rigid contact lenses for the last three weeks or soft contact lenses for at least 1 week before the preoperative evaluation.

Design outcomes

Primary

MeasureTime frame
Visual acuity corrected and uncorrected, wavefront aberrationsTimepoint: Pre-surgery, 1 week, 1 month, 3 month, 6 month

Secondary

MeasureTime frame
Corneal tomography and biomechanical responseTimepoint: Pre-surgery, 1 week, 1 month, 3 month, 6 month

Countries

India

Contacts

Public ContactDr Rohit Shetty

Narayana Nethralaya

drrohitshetty@yahoo.com9611102568

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026