Clinical TrialID 6701
Use of Cross-linked Donor Corneas as Carriers for the Boston Keratoprosthesis
NCT01582880
Chemical Injuries|Unspecified Complication of Corneal Transplant|Autoimmune Diseases|Ocular Cicatricial Pemphigoid|Stevens Johnson Syndrome|Lupus Erythematosus, Systemic|Rheumatoid Arthritis|Other Autoimmune Diseases
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 6701
- Evidence Id
- 6701
- Core Evidence Id
- 6701
- Source Clinical Trial Id
- 6688
- Herb2 Clinical Trial Id
- HBCT006688
- Nct Id
- NCT01582880
- Title
- Use of Cross-linked Donor Corneas as Carriers for the Boston Keratoprosthesis
- Status
- Completed
- Phase
- Phase 1|Phase 2
- Study Result
- Yes
- Study Condition
- Chemical Injuries|Unspecified Complication of Corneal Transplant|Autoimmune Diseases|Ocular Cicatricial Pemphigoid|Stevens Johnson Syndrome|Lupus Erythematosus, Systemic|Rheumatoid Arthritis|Other Autoimmune Diseases
- Study Type
- Interventional
- Study Design
- Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
- Intervention
- DRUG: Riboflavin
- Intervention Allocation
- Intervention Model
- Single_Group
- Intervention Mask
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Adult, Older_Adult
- Enrollment
- 1
- Outcome Measure
- Changes in Corneal Thickness at 1 Millimeter, The average carrier graft thickness over the first year of postoperative follow-up. The corneal thickness was measured at each visit using AS-OCT imaging 1 mm away from the KPro stem at 3, 6, 9, and 12 o'clock. The individual corneal thickness measurements (3, 6, 9, and 12 o'clock) where then averaged. The average corneal thickness measurements for week 4, 6, 26, 32 and 52 are reported below., measured at week 4, 6, 26, 32, 52|Changes in Corneal Thickness at 2 Millimeter, The average carrier graft thickness over the first year of postoperative follow-up. The corneal thickness was measured at each visit using AS-OCT imaging 2 mm away from the KPro stem at 3, 6, 9, and 12 o'clock. The individual corneal thickness measurements (3, 6, 9, and 12 o'clock) where then averaged. The average corneal thickness measurements for week 4, 6, 26, 32 and 52 are reported below., measured at week 4, 6, 26, 32, 52
- Sponsor Collaborator
- Joseph B. Ciolino, MD
- Funded By
- OTHER
- Location
- Massachusetts Eye and Ear Infirmary, Boston, Massachusetts, 02114, United States
- Other Id
- 10-03-020
- Start Date
- 2012-03
- Primary Completion Date
- 2014-03
- Completion Date
- 2014-03
- First Posted
- 2012-04-23
- Results First Posted
- 2017-07-24
- Last Update Posted
- 2019-10-21
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT01582880
- Title Cn
- Title En
- Use of Cross-linked Donor Corneas as Carriers for the Boston Keratoprosthesis
- Bilingual Status
- semi_complete