Keratoconus is characterized by a thinning of the cornea, which causes a decrease in visual acuity due to astigmatism.
Publications suggest that keratoconus is linked to chronic inflammation (increase in pro-inflammatory cytokines and metalloproteinases (MMP). Direct epithelial-stromal interactions (D-ESI) have a role in the induction of metalloproteinases (MMP) and the differentiation of fibroblasts into myofibroblasts via an EMMPRIN membrane glycoprotein (extracellular matrix membran MMP inducer - CD 147). On a healthy cornea, EMMPRIN's effects are prevented by a lack of contact between epithelial and stromal cells through a basement membrane, which is altered in the keratoconus The hypothesis is that stromal thinning of the keratoconus could be related to increased expression of EMMPRIN by epithelial and stromal cells (resulting in increased MMP synthesis), with a preponderance at the most deformed areas.
The main objective is to demonstrate a transformation of fibroblasts to myofibroblasts in the corneal stroma of keratoconus patients.
Condition or disease | Intervention/treatment |
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Keratoconus | Procedure: Corneal sampling |
Study Type : | Observational |
Actual Enrollment : | 0 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | Myofibroblastic Transformation Secondary to Epithelial-stromal Interactions in the Keratoconus (MYKE) |
Actual Study Start Date : | November 1, 2019 |
Actual Primary Completion Date : | May 12, 2020 |
Actual Study Completion Date : | May 12, 2020 |
Group/Cohort | Intervention/treatment |
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Cases
Patients suffering from keratoconus and requiring a first optical corneal transplant
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Procedure: Corneal sampling
Corneal samples will be taken during corneal transplants for cases and orbital exenterations for controls. The mRNA (messenger ribonucleic acid) will be extracted and a retrotranscription will be made to obtain cDNA (complementary DNA). A qPCR (quantitative polymerase chain reaction) will be able to quantify the expression of alpha-SMA, MMP 1-2-3 and 9, and EMMPRIN.
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Controls
Patients with an indication of orbital exenteration operation due to an orbital tumor
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Procedure: Corneal sampling
Corneal samples will be taken during corneal transplants for cases and orbital exenterations for controls. The mRNA (messenger ribonucleic acid) will be extracted and a retrotranscription will be made to obtain cDNA (complementary DNA). A qPCR (quantitative polymerase chain reaction) will be able to quantify the expression of alpha-SMA, MMP 1-2-3 and 9, and EMMPRIN.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
For the cases :
- Suffering from keratoconus and requiring a first optical corneal transplant
For the controls:
Exclusion Criteria:
For the cases:
For the controls:
No Contacts or Locations Provided
Tracking Information | |||||
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First Submitted Date | June 11, 2019 | ||||
First Posted Date | June 19, 2019 | ||||
Last Update Posted Date | May 14, 2020 | ||||
Actual Study Start Date | November 1, 2019 | ||||
Actual Primary Completion Date | May 12, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
Comparison of alpha-SMA's (Smooth Muscle Actin) messenger RNA expression evaluated by quantitative PCR (RT-qPCR) in corneal stroma in keratoconus patients compared to non-keratoconus controls [ Time Frame: 12 hours ] | ||||
Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures | Not Provided | ||||
Original Secondary Outcome Measures | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Myofibroblastic Transformation Secondary to Epithelial-stromal Interactions in the Keratoconus | ||||
Official Title | Myofibroblastic Transformation Secondary to Epithelial-stromal Interactions in the Keratoconus (MYKE) | ||||
Brief Summary |
Keratoconus is characterized by a thinning of the cornea, which causes a decrease in visual acuity due to astigmatism. Publications suggest that keratoconus is linked to chronic inflammation (increase in pro-inflammatory cytokines and metalloproteinases (MMP). Direct epithelial-stromal interactions (D-ESI) have a role in the induction of metalloproteinases (MMP) and the differentiation of fibroblasts into myofibroblasts via an EMMPRIN membrane glycoprotein (extracellular matrix membran MMP inducer - CD 147). On a healthy cornea, EMMPRIN's effects are prevented by a lack of contact between epithelial and stromal cells through a basement membrane, which is altered in the keratoconus The hypothesis is that stromal thinning of the keratoconus could be related to increased expression of EMMPRIN by epithelial and stromal cells (resulting in increased MMP synthesis), with a preponderance at the most deformed areas. The main objective is to demonstrate a transformation of fibroblasts to myofibroblasts in the corneal stroma of keratoconus patients. |
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Detailed Description | Not Provided | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Case-Control Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population | Keratoconus patients requiring first optical corneal transplantation and controls with indication of orbital exenteration due to an orbital tumor. | ||||
Condition | Keratoconus | ||||
Intervention | Procedure: Corneal sampling
Corneal samples will be taken during corneal transplants for cases and orbital exenterations for controls. The mRNA (messenger ribonucleic acid) will be extracted and a retrotranscription will be made to obtain cDNA (complementary DNA). A qPCR (quantitative polymerase chain reaction) will be able to quantify the expression of alpha-SMA, MMP 1-2-3 and 9, and EMMPRIN.
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Study Groups/Cohorts |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Withdrawn | ||||
Actual Enrollment |
0 | ||||
Original Estimated Enrollment |
60 | ||||
Actual Study Completion Date | May 12, 2020 | ||||
Actual Primary Completion Date | May 12, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | Not Provided | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03990740 | ||||
Other Study ID Numbers | EGN_2017_22 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Fondation Ophtalmologique Adolphe de Rothschild | ||||
Study Sponsor | Fondation Ophtalmologique Adolphe de Rothschild | ||||
Collaborators | Not Provided | ||||
Investigators | Not Provided | ||||
PRS Account | Fondation Ophtalmologique Adolphe de Rothschild | ||||
Verification Date | May 2020 |