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

January 30, 2024 updated by: Tianjin Eye Hospital

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Luxia Chen，PHD,MD, Doctorate
  • Phone Number: +8618202287817 Telephone: 022-27313336
  • Email: Chen2006317@126.com

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China
        • Recruiting
        • TianJin eye hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients premedicated for keratoplasty surgery

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A Novel Sandwich Technique for Corneal Perforation
Time Frame: 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.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Eye Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 23, 2020

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

January 23, 2024

First Submitted That Met QC Criteria

January 30, 2024

First Posted (Estimated)

January 31, 2024

Study Record Updates

Last Update Posted (Estimated)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • zhangyi2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Corneal Perforation, Corneal Stromal Lenticule,Sandwich Technique

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