Tissue Engineering Conjunctiva for the Treatment of Pterygium and Atretoblepharia

Not Applicable

• Conditions: Pterygium
• Interventions: Procedure: Tissue engineering conjunctiva transplantation

• Registration Number: NCT02911532
• Lead Sponsor: Shandong Eye Hospital

Brief Summary

The purpose of this study is to determine whether tissue engineering conjunctiva is effective in the treatment of pterygium and atretoblepharia.

Detailed Description

The most important area for research on the pterygium are the recurrence occurred after operation. Now the best way to prevent the recurrence is autologous conjunctival stem cell transplantation, but this way of operation can cause lack of conjunctiva and conjunctival scar, even may effect the later glaucoma surgery. For the atretoblepharia patients, amniotic membrane transplantation and autologous oral mucosa transplantation can not make effect to alleviate it. In this pilot project, investigators would like to study the effect of tissue engineering conjunctiva transplantation in the treatment of pterygium and tissue engineering conjunctiva transplantation combined with conjunctiva sac formation for the treatment of atretoblepharia. This will allow us to determine if useful data can be obtained, and if so, lead to further studies in various conjunctiva loss caused by trauma, infections, and so on.

Study Timeline

• Study First Submitted: 2016-08-26
• Study First Submitted QC: 2016-09-19
• Study First Posted: 2016-09-22
• Study Start: 2016-10-01
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-12
• Last Update Posted: 2017-08-16
• Primary Completion: 2017-10-01
• Study Completion: 2018-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Primary and recurrent pterygium patients,atretoblepharia patients
2. Voluntarily signed informed consent
3. No surgery and anesthesia contraindications.

Exclusion Criteria

1. The patients combined systemic diseases
2. Reject study and follow visit
3. Patients don't accept the tissue engineering conjunctiva
4. Cannot tolerate surgery or anesthesia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Optical Coherence tomography	Tissue engineering conjunctiva transplantation	-

Primary Outcome Measures

Name	Time	Method
The epithelial defect size of the transplanted tissue engineering conjunctiva	the 7 days after operation

Trial Locations

Locations (1)

Shandong Eye Hospital; 🇨🇳 Jinan, Shandong, China