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A Novel Sandwich Technique of Minimally Invasive Keratoplasty for Corneal Perforation (STMIK)

T

Tianjin Eye Hospital

Status

Enrolling

Conditions

Corneal Perforation, Corneal Stromal Lenticule,Sandwich Technique

Study type

Observational

Funder types

Other

Identifiers

NCT06233409
zhangyi2023

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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.

Trial design

30 participants in 2 patient groups

lenticules group
Description:
Morphology of cornea and intra-ocular pressure were obtained by optical coherence tomography, Non-contact tonometer, Slit-lamp photography
Penetrating keratoplasty group
Description:
Morphology of cornea and intra-ocular pressure were obtained by optical coherence tomography, Non-contact tonometer, Slit-lamp photography

Trial contacts and locations

1

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Central trial contact

Luxia Chen,PHD,MD, Doctorate

Data sourced from clinicaltrials.gov

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