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Contrast of irrigation the Corneal Stromal Pocket in SMILE

Contrast of irrigation the Corneal Stromal Pocket in SMILE

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900022049
Enrollment
Unknown
Registered
2019-03-22
Start date
2018-02-01
Completion date
Unknown
Last updated
2019-03-25

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

Conditions

Ametropia

Interventions

irrigation group:irrigation the Corneal Stromal Pocket
non-irrigation group:No

Sponsors

Hainan Ophthalmological Hospital of Zhongshan Ophthalmological Center of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1) The patients themselves have the desire to improve refractive status through SMILE, and have reasonable expectations for the effect of surgery. 2) Myopia and astigmatism patients aged 18 years and over (except for special cases, such as job-hunting requirements, high anisometropia, etc.). Before operation, on the basis of full understanding, the patients themselves or their family members should sign the informed consent together if necessary. 3) Diopter: relatively stable (the change of diopter in the past year is less than 0.50 D). The range is spherical - 1.00 - 10.00 D and cylindrical - 5.00 D. 4) Cornea: transparent without obvious clouds or patches; corneal topographic examination showed normal morphology and no keratoconus tendency. 5) There were no other eye diseases and/or systemic organic lesions affecting the recovery of surgery. 6) The contraindication of operation was excluded by preoperative examination.

Exclusion criteria

Exclusion criteria: 1) The patient's head position can not be in normal position. 2) Severe amblyopia. 3) keratoconus or suspected keratoconus. 4) Other corneal dilatation and degeneration. 5) Recent recurrent corneal diseases such as viral keratitis. 6) Severe dry eye and Sjogren's syndrome. 7) The cornea is too thin. It is estimated that the thickness of residual stromal bed in the central cornea after lens removal is less than 250 um. (In general, the residual thickness of corneal stromal bed should be at least > 250 um, and it is recommended that the thickness of residual stromal bed be more than 280 um.) 8) There are active ocular lesions or infections. 9) Severe ocular adnexal lesions, such as eyelid defect and deformation, and severe eyelid insufficiency. 10) Uncontrolled glaucoma, cataract seriously affecting vision, serious corneal diseases, such as obvious corneal opacity, marginal corneal degeneration, corneal stromal or endothelial dystrophy and other corneal diseases, corneal trauma, serious ocular surface and fundus diseases after corneal transplantation, radial keratotomy and other corneal operations. 11) There are systemic connective tissue diseases or autoimmune diseases, such as systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis and so on. 12) Severe mental and psychiatric disorders such as anxiety and depression are known to exist. 13) Systemic or psychiatric disorders, such as epilepsy and hysteria, resulting in diseases that are unable to cooperate with examinations and operations.

Design outcomes

Primary

MeasureTime frame
Corneal density;Corneal biomechanics;Vision;Corneal endothelial cells;Cross-sectional morphology of cornea ;

Countries

china

Contacts

Public ContactXingwu Zhong

Hainan Ophthalmological Hospital of Zhongshan Ophthalmological Center of Sun Yat-sen University

zhongxwu@mail.sysu.edu.cn+86 13609649279

Outcome results

None listed

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