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Evaluation of the safety and effectiveness of SMART combined with accelerated corneal cross-linking in the correction of myopia

Evaluation of the safety and effectiveness of SMART combined with accelerated corneal cross-linking in the correction of myopia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094224
Enrollment
Unknown
Registered
2024-12-19
Start date
2024-12-20
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

Ametropia

Interventions

SMART Xtra group:Accelerated corneal cross-linking
SMART group:None

Sponsors

Affiliated Eye Hospital of Shandong University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: SMART Group: 1. Age>=18 years; 2. Diopter is -8.00D and below, astigmatism is -4.00D and below; 3. Stop wearing spherical soft lenses for more than 2 weeks, stop wearing soft lenses for astigmatism and hard oxygen-permeable contact lenses for more than 4 weeks, and stop wearing orthokeratology lenses for more than 12 weeks; 4. The refractive state has been basically stable for more than 2 years (the annual increase in myopia refractive power does not exceed 0.50D) (in line with the "Expert Consensus on Clinical Diagnosis and Treatment of Laser Corneal Refractive Surgery 2021"); 5. Postoperative corneal thinnest point thickness>=360µm; SMART Xtra group: in addition to meeting the above conditions, the CBI measured by Pentacam corneal topography combined with Corvis ST was > 0.5 and TBI > 0.3 (the value greater than 0.3 indicates that the cornea is at risk of dilation), and the corneal thickness was uniformly distributed by anterior segment OCT analysis, and the anterior and posterior surface morphology of the cornea was normal, S-I (2-5 mm) < = 31 µm, SN-IT (2-5 mm) < = 48 µm;

Exclusion criteria

Exclusion criteria: 1. Patients with a history of other eye diseases and ocular trauma diseases other than refractive error; 2. Patients with suspected or confirmed keratoconus, or other types of corneal ectasia; 3. Patients with refractive errors caused by genetic or congenital factors that are difficult to correct; 4. Other ocular diseases and/or systemic organic lesions that affect corneal wound healing (in line with the Expert Consensus on Clinical Diagnosis and Treatment of Laser Corneal Refractive Surgery 2021); 5. Patients with corneal diseases or corneal dystrophy who do not meet the indications for surgery (in line with the Expert Consensus on Transepithelial Excimer Laser Keratomectomy in China (2019)); (5) Patients with corneal diseases or corneal dystrophy that do not meet the indications for surgery (in accordance with the Chinese Expert Consensus on Transsuperficial Excimer Laser Keratomileusis (2019));

Design outcomes

Primary

MeasureTime frame
Uncorrected visual acuity(UCVA);Spherical equivalent (SE);Central corneal thickness (CCT);Thinnest corneal thickness (TCT);Cornea keratometry ;Corneal biomechanical index;Cornea densito;Corneal higher-order aberration (HOA);

Countries

China

Contacts

Public ContactJi Peng

Affiliated Eye Hospital of Shandong University of Traditional Chinese Medicine

ji6605@126.com+86 135 7375 3812

Outcome results

None listed

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