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Comparison of early visual outcomes after SMILE using VISUMAX 800 and VISUMAX 500 for myopia: an ambispective, observational, single-center study

Comparison of early visual outcomes after SMILE using VISUMAX 800 and VISUMAX 500 for myopia: an ambispective, observational, single-center study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500112227
Enrollment
Unknown
Registered
2025-11-11
Start date
2025-06-24
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Refractive error

Interventions

Observation Group Visumax 500:None
Observation Group Visumax 800:None

Sponsors

Guangzhou Aier Eye Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1.The patient has reasonable expectations for the procedure; 2.Age: 18-40 years; 3.Myopia: -1 D to -10 D, astigmatism: -5 D; 4.Refractive error: within 0.5 D within two years.

Exclusion criteria

Exclusion criteria: 1.The patient's head cannot be positioned normally; 2.severe amblyopia; 3.keratoconus or suspected keratoconus or other ectatic diseases or corneal degeneration; 4.active inflammation of the eyelids and ocular surface, recent recurrent viral keratitis; 5.significant corneal scarring; 6.severe dry eye, Sjögren's syndrome; 7.thin cornea, with the remaining corneal stromal bed thickness less than 280µm after surgery; 8.severe ocular adnexal disease, eyelid coloboma or deformity, severe incomplete eyelid closure; 9.uncontrolled glaucoma; 10.severe cataracts that affect vision; 11.systemic connective tissue disease or autoimmune disease; 12.severe psychological or psychiatric problems such as anxiety and depression; 13.systemic or psychiatric illnesses, such as epilepsy or hysteria, that prevent the patient from cooperating with examination and surgery.

Design outcomes

Primary

MeasureTime frame
Uncorrected distance visual acuity;

Secondary

MeasureTime frame
Corneal topography & tomography;Manifest refraction;Visual quality Questionaire;Complication;Contrast sensitivity;

Countries

China

Contacts

Public ContactXiong Lu

Guangzhou Aier Eye Hospital

xlpm@qq.com+86 20 8731 3301

Outcome results

None listed

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