A Novel Sandwich Technique of Minimally Invasive Keratoplasty for Corneal Perforation

NCT06233409 | Unknown

• 1 other identifier: zhangyi2023
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Corneal Perforation, Corneal Stromal Lenticule,Sandwich Technique

Keywords

Corneal perforation, Corneal stromal lenticule,Sandwich technique

Outcome Measures

Primary Outcomes (1)

• A Novel Sandwich Technique for Corneal Perforation

  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

Study Arms (2)

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

Eligibility Criteria

• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients premedicated for keratoplasty surgery

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tianjin Eye Hospital: lead

Study Sites (1)

Tianjin Eye Hospital

Tianjin, Tianjin Municipality, China

RECRUITING

MeSH Terms

Conditions

Corneal Perforation

Condition Hierarchy (Ancestors)

Corneal Injuries; Eye Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Corneal Diseases; Eye Diseases; Wounds and Injuries

Central Study Contacts

Luxia Chen，PHD,MD, Doctorate

CONTACT

Telephone: 022-27313336; Chen2006317@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: January 31, 2024
• Study Start: October 23, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 31, 2024

Record last verified: 2024-01

Locations

CN (1)