A Novel Sandwich Technique of Minimally Invasive Keratoplasty for Corneal Perforation

Recruiting

• Conditions: Corneal Perforation, Corneal Stromal Lenticule,Sandwich Technique

• Registration Number: NCT06233409
• Lead Sponsor: Tianjin Eye Hospital

Brief Summary

The goal of this type of study to describe a new sandwich technique of minimally invasive keratoplasty (STMIK) by using SMILE-extracted lenticules for treatment corneal perforation and effectiveness.

The main question\[s\] it aims to answer are: 1.Corneal perforations require urgent attendances for prompt treatments. How can we restore the integrity of the eyeball as soon as possible, reduce complications, and restore vision in the case of lack of corneal material according to the conditions that may be obtained.

2.In China, nearly 1 million lenticules are obtained through all-femtosecond surgery every year. How to reuse and turn waste into precious materials for clinical application is an important study.

Participants will understand and signed the informed consent to take this new method for the treatment of their corneal perforations disease, which will obtain good results, but there may be a certain risk of complications.The main tasks participants will be asked to cooperate as required.The clinical eye check includes the test of includes visual acuity, slit lamp, anterior segment phase, anterior segment OCT and IOP.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-23
• Status Verified: 2024-01
• Study First Submitted: 2024-01-23
• Study First Submitted QC: 2024-01-30
• Last Update Submitted: 2024-01-30
• Study First Posted: 2024-01-31
• Last Update Posted: 2024-01-31
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Patients with corneal perforation who are willing to undergo treatment with this new technique;
2. The size of cornea perforation was ≦ 3mm

Exclusion Criteria

1. The size of cornea perforation was >3mm
2. Patients with corneal perforation who were unwilling to be treated with this new technique.
3. Patients who could not be followed up regularly.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A Novel Sandwich Technique for Corneal Perforation	one year	By sandwiching the corneal lenticules interlamellar implantation, STMIK as an alternative novel treatment and effective procedure that provides an option to restore the corneal integrity and improve vision in patients with corneal perforations.

Trial Locations

Locations (1)

Tianjin Eye Hospital; 🇨🇳 Tianjin, Tianjin, China