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A Clinical trial comparing corneal morphological (changes in structure, thickness) and biomechanical (corneal strength changes) Outcomes of Femtosecond laser assisted LASIK refractive surgery with two machines namely Visumax -MEL90 and Wavelight FS200-EX500 Lasers

Comparison of Morphological and Biomechanical Outcomes of FS-LASIK with Visumax-MEL90 and Wavelight FS200-EX500 Lasers- a Randomised Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/05/052980
Enrollment
110
Registered
2023-05-22
Start date
Unknown
Completion date
Unknown
Last updated
2023-06-26

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

Conditions

Health Condition 1: H521- Myopia

Interventions

Intervention1: FS-LASIK with Visumax MEL90: The laser system has a low suction pressure of about 35mmHg with a suction time is about 30 seconds. It Creates corneal flap by acurvation method by mainta

Sponsors

Dr Rajendra Prasad Centre for Ophthalmic Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Patients undergoing FS-LASIK for myopia or myopic astigmatism 2)Stable refractive error for >1 year 3)Minimum calculated RSBT- 300 microns 4)Patients willing to give informed consent 5)Patients willing for follow up

Exclusion criteria

Exclusion criteria: 1)Progressive or unstable myopia 2)External ocular disease/ keratoconus (including forme-fruste)/ Pellucid marginal degeneration. 3)Diabetes, connective tissue disease, Atopy; pregnant or nursing patients. 4)Corticosteriods or antimetabolites use 5)Previous corneal surgery/ Re-treatment, not willing to follow up. 6)Soft contact lens use in past 2 weeks or rigid gas permeable contact lens wear in past 4 weeks.

Design outcomes

Primary

MeasureTime frame
Central Flap ThicknessTimepoint: Day 1, 1 week, 1 month, 3 months—

Secondary

MeasureTime frame
1)Corneal Biomechanical outcomes (Including DA, A length, A velocity, CBI-LVC index) 2)Anterior chamber angle parameters (ACD, ARA, TIA, TISA, AOD) 3)Posterior Segment Changes (Bursa premacularis, Area of Martigiani, RNFL thickness , GCL thickness, CMT) 4)Flap shape, regularity, accuracy 5)Visual Quality (HOAs, Strehl Ratio, MTF, PSF) 6)Suction timeTimepoint: Day 1, 1 week, 1 month, 3 months—

Countries

India

Contacts

Public ContactDr Venkatesh Antalmarad

ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI

titiyal@gmail.com01126593146

Outcome results

None listed

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