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Outcomes comparison between wavelight plus and SMILE for myopia and myopic astigmatism

Outcomes comparison between wavelight plus and SMILE for myopia and myopic astigmatism

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093664
Enrollment
Unknown
Registered
2024-12-10
Start date
2024-12-16
Completion date
Unknown
Last updated
2024-12-16

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

Conditions

Myopia and myopic astigmatism

Interventions

Customed FS-LASIK group(wavelight plus):Customed FS-LASIK(wavelight plus) was performed based on the principle of whole eye aberration tracing.
SMILE group:The surgery of femtosecond laser small incision lenticule extraction (SMILE, Visumax500) was performed.

Sponsors

Beijing Tongren Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1) Myopic patients aged 18-40 years; 2) Preoperative degree of myopic sphere from -0.5D to -8D, spherical equivalent(SE)<=-11D, myopic astigmatism <=-3.0D, in line with the treatment degree of wavelight plus or SMILE ; 3)The preoperative best corrected visual acuity(BCVA) is 20/20; 4) Stable refraction (SE growth does not exceed 0.5D 1 year before surgery), the difference of manifest refractive spherical equivalent(MRSE) and sightmap aberration detector does not exceed 0.5D; 5) No eye surgery history, being able to complete the follow-up; The number of patients with low, moderate and high myopia was roughly the same in both groups.

Exclusion criteria

Exclusion criteria: 1) Central corneal thickness <480µm; 2) Postoperative predictive residual stromal bed(RSB) thickness <280µm; 3) Clinically significant corneal abnormalities include corneal degeneration, keratoconus, corneal scar at optic axis, anterior basement membrane dystrophy, etc; 4) Moderate to severe dry eye; 5) Retinal diseases or optic neuropathy that affect vision; 6) Cataract; 7) Glaucoma; 8) Pregnancy or lactation.

Design outcomes

Primary

MeasureTime frame
UDVA of 3 months after surgery (uncorrected distance visual acuity);

Secondary

MeasureTime frame
Mean uncorrected distance visual acuity(UDVA);Mean corrected distance visual acuity(CDVA);Manifest refractive spherical equivalent(MRSE);HOA(Total higher order aberration, coma, spherical aberration);Percentage of UDVA more than 1 line,2 lines or over 2 lines before the surgery;Percentage of UDVA reaches 20/10,20/12.5,20/16,20/20,20/25,and20/32;Percentage of MRSE in range of ±0.25D,±0.50D,±075D,and±1.0D;Percentage of residual astigmatism in range of -0.25D,-0.50D,-0.75D,and-1.0D;

Countries

China

Contacts

Public ContactZhai Changbin

Beijing Tongren Hospital, Capital Medical University

eyedrzcb@163.com+86 136 0108 9269

Outcome results

None listed

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