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The clinical study of corneal lenticule transplantation with small incision lenticule extraction (SMILE)

The clinical study of corneal lenticule transplantation with small incision lenticule extraction (SMILE)

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OIC-16008307
Enrollment
Unknown
Registered
2016-04-19
Start date
2016-04-14
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

refractive error with thin cornea, cornea pathology, keratoconus

Interventions

1:lenticule transplantation with small incision lenticule extraction (SMILE)

Sponsors

Department of Ophthalmology, Eye and ENT Hospital of Fudan University, Myopia Key Laboratory of the Health Ministry
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Be at least 18 years of age, male or female, of any race; 2. Provide written informed consent; 3. Willingness and ability to follow all instructions and comply with schedule for follow-up visits; 4. Diagnosed as refractive error with thin cornea, cornea pathology, or keratoconus; 5. Contact Lens Wearers Only: Removal of contact lenses for the required period of time prior to the screening refraction: Contact Lens Type Minimum Discontinuation TimeSoft 1 WeekSoft Extended Wear 1 WeekSoft Toric 2 Weeks Rigid gas permeable 2 Weeks.

Exclusion criteria

Exclusion criteria: 1. current use of any medication due to a psychiatric disorder or cognitive impairment that might affect the psychological assessment; 2. subjects who had undergone ocular surgery within the last 6 months; 3. Pregnancy (including plans to become pregnant) or lactation during the course of the study; 4. Patients with nystagmus or any other condition that would prevent a steady gaze during the treatment or other diagnostic tests.

Design outcomes

Primary

MeasureTime frame
efficacy index;safety index;biomechanics;slit lamp observation;Confocal microscope;OCT observation;corneal structure changes;optical quality;contrast sensitivity;corneal sensitivity;

Countries

China

Contacts

Public ContactXingtao Zhou

Department of Ophthalmology, Eye and ENT Hospital of Fudan University, Myopia Key Laboratory of the Health Ministry

doctzhouxingtao@163.com+86 13816880725

Outcome results

None listed

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