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Corneal Stroma Implantation for the Treatment of Keratoconus

Primary Purpose

Keratoconus

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
corneal stroma implantation
Sponsored by
Shandong Eye Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconus

Eligibility Criteria

15 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Advanced and completed keratoconus patients
  2. Voluntarily signed informed consent
  3. No surgery and anesthesia contraindications

Exclusion Criteria:

  1. Acute edema of cornea
  2. Primary keratoconus patients
  3. The patients combined systemic diseases
  4. Reject study and follow visit
  5. Cannot tolerate surgery or anesthesia

Sites / Locations

  • Shandong Eye HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

corneal stroma implantation

Arm Description

implant the corneal stroma to the diseased cornea of keratoconus patients

Outcomes

Primary Outcome Measures

The best corrected visual acuity of the operated eye
To check whether the best corrected visual acuity，which is scaled by the integrated refractometer,is improved after surgery.
The best corrected visual acuity of the operated eye
To check whether the best corrected visual acuity，which is scaled by the integrated refractometer,is improved after surgery.
The best corrected visual acuity of the operated eye
To check whether the best corrected visual acuity，which is scaled by the integrated refractometer,is improved after surgery.
The best corrected visual acuity of the operated eye
To check whether the best corrected visual acuity，which is scaled by the integrated refractometer,is improved after surgery.

Secondary Outcome Measures

The biomechanics of the operated eye
To check whether the biomechanics,which is scaled by the corvis ST is improved after surgery.
The biomechanics of the operated eye
To check whether the biomechanics,which is scaled by the corvis ST is improved after surgery.
The biomechanics of the operated eye
To check whether the biomechanics,which is scaled by the corvis ST is improved after surgery.
The biomechanics of the operated eye
To check whether the biomechanics,which is scaled by the corvis ST is improved after surgery.

Full Information

First Posted
July 16, 2017
Last Updated
August 22, 2017
Sponsor
Shandong Eye Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03229239
Brief Title
Corneal Stroma Implantation for the Treatment of Keratoconus
Official Title
Implant the Corneal Stroma to the Diseased Cornea in Order to Cure Keratoconus
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 11, 2017 (Actual)
Primary Completion Date
August 11, 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shandong Eye Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether corneal stroma implantation is effective in the treatment of keratoconus.
Detailed Description
Keratoconus is a corneal disease with the progressive thinning of the central corneal stroma. The main treatment methods are corneal transplantation, corneal collagen cross-linking, etc. The effect of corneal collagen cross-linking is limited, and the lack of donor cornea is really a very big problem. In this pilot project, investigators would like to study whether corneal stroma implantation can increase the biomechanics of the cornea, which can, to some extent, delay the progress of keratoconus. This will allowed us to determine if useful data can be obtained, and if so, the donor cornea can be greatly saved.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
corneal stroma implantation
Arm Type
Experimental
Arm Description
implant the corneal stroma to the diseased cornea of keratoconus patients
Intervention Type
Procedure
Intervention Name(s)
corneal stroma implantation
Intervention Description
During the operation,implant the corneal stroma to the diseased cornea of keratoconus.
Primary Outcome Measure Information:
Title
The best corrected visual acuity of the operated eye
Description
To check whether the best corrected visual acuity，which is scaled by the integrated refractometer,is improved after surgery.
Time Frame
1 month after operation
Title
The best corrected visual acuity of the operated eye
Description
To check whether the best corrected visual acuity，which is scaled by the integrated refractometer,is improved after surgery.
Time Frame
3 months after operation
Title
The best corrected visual acuity of the operated eye
Description
To check whether the best corrected visual acuity，which is scaled by the integrated refractometer,is improved after surgery.
Time Frame
6 months after operation
Title
The best corrected visual acuity of the operated eye
Description
To check whether the best corrected visual acuity，which is scaled by the integrated refractometer,is improved after surgery.
Time Frame
12 months after operation
Secondary Outcome Measure Information:
Title
The biomechanics of the operated eye
Description
To check whether the biomechanics,which is scaled by the corvis ST is improved after surgery.
Time Frame
1 month after operation
Title
The biomechanics of the operated eye
Description
To check whether the biomechanics,which is scaled by the corvis ST is improved after surgery.
Time Frame
3 months after operation
Title
The biomechanics of the operated eye
Description
To check whether the biomechanics,which is scaled by the corvis ST is improved after surgery.
Time Frame
6 months after operation
Title
The biomechanics of the operated eye
Description
To check whether the biomechanics,which is scaled by the corvis ST is improved after surgery.
Time Frame
12 months after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Advanced and completed keratoconus patients Voluntarily signed informed consent No surgery and anesthesia contraindications Exclusion Criteria: Acute edema of cornea Primary keratoconus patients The patients combined systemic diseases Reject study and follow visit Cannot tolerate surgery or anesthesia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mingna Liu, researcher
Phone
8613589089612
Email
lmn_2422@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hua Gao, researcher
Phone
8613705312702
Email
gaohua100@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weiyun Shi, sponsor
Organizational Affiliation
director of shandong eye hosiptal
Official's Role
Study Chair
Facility Information:
Facility Name
Shandong Eye Hospital
City
Jinan
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suxia Li, Doctor
Phone
15854107085
Email
ykyykjk@163.com
First Name & Middle Initial & Last Name & Degree
Weiyun Shi, Doctor
Phone
13953218357
Email
weiyunshi@163.com
First Name & Middle Initial & Last Name & Degree
Hua Gao, Doctor

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Corneal Stroma Implantation for the Treatment of Keratoconus

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