Corneal Stroma Implantation for the Treatment of Keratoconus
Implant the Corneal Stroma to the Diseased Cornea in Order to Cure Keratoconus
1 other identifier
interventional
60
1 country
1
Brief Summary
The purpose of this study is to determine whether corneal stroma implantation is effective in the treatment of keratoconus.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 16, 2017
CompletedFirst Posted
Study publicly available on registry
July 25, 2017
CompletedStudy Start
First participant enrolled
August 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 11, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedAugust 24, 2017
August 1, 2017
1 year
July 16, 2017
August 22, 2017
Conditions
Outcome Measures
Primary Outcomes (4)
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.
1 month after operation
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.
3 months after operation
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.
6 months after operation
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.
12 months after operation
Secondary Outcomes (4)
The biomechanics of the operated eye
1 month after operation
The biomechanics of the operated eye
3 months after operation
The biomechanics of the operated eye
6 months after operation
The biomechanics of the operated eye
12 months after operation
Study Arms (1)
corneal stroma implantation
EXPERIMENTALimplant the corneal stroma to the diseased cornea of keratoconus patients
Interventions
During the operation,implant the corneal stroma to the diseased cornea of keratoconus.
Eligibility Criteria
You may qualify if:
- Advanced and completed keratoconus patients
- Voluntarily signed informed consent
- No surgery and anesthesia contraindications
You may not qualify if:
- Acute edema of cornea
- Primary keratoconus patients
- The patients combined systemic diseases
- Reject study and follow visit
- Cannot tolerate surgery or anesthesia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shandong Eye Hospital
Jinan, Shandong, China
Related Publications (1)
Li N, Liu M, Tian G, Chen T, Lin Y, Qi X, Shi W, Gao H. Effects of femtosecond laser-assisted minimally invasive lamellar keratoplasty (FL-MILK) on mild-to-moderate and advanced keratoconus. Graefes Arch Clin Exp Ophthalmol. 2023 Oct;261(10):2873-2882. doi: 10.1007/s00417-023-06093-2. Epub 2023 May 12.
PMID: 37171602DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Weiyun Shi, sponsor
director of shandong eye hosiptal
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2017
First Posted
July 25, 2017
Study Start
August 11, 2017
Primary Completion
August 11, 2018
Study Completion
December 1, 2018
Last Updated
August 24, 2017
Record last verified: 2017-08