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NCT01582880 · ClinicalTrials.gov registry record · Phase 1
Use of Cross-linked Donor Corneas as Carriers for the Boston Keratoprosthesis
A Phase 1 study of Rheumatoid Arthritis and Lupus Erythematosus, Systemic, sponsored by Joseph B. Ciolino, MD.
- Completed
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
- 1
- Study location
NCT01582880: Completed Phase 1 study of Rheumatoid Arthritis and Lupus Erythematosus, Systemic, sponsored by Joseph B. Ciolino, MD.
NCT01582880 is a Phase 1 study of Rheumatoid Arthritis and Lupus Erythematosus, Systemic that has completed, run by Joseph B. Ciolino, MD. The registered enrollment target is 1 participants, below the 4,691-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01582880, a Phase 1 study of Rheumatoid Arthritis and Lupus Erythematosus, Systemic, has completed, sponsored by Joseph B. Ciolino, MD.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of the pilot study is to test the efficacy and safety of riboflavin/Ultraviolet A (UVA) cross-linked human donor corneas as carriers for the Boston Keratoprosthesis (Boston KPro) in patients with higher risk for corneal melting (keratolysis).
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Riboflavin
Study Locations (1)
Massachusetts
- Massachusetts Eye and Ear Infirmary - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2012-03 |
| Est. Completion | 2014-03 |
| Phase | Phase 1 |
What the finished NCT01582880 record still lists
NCT01582880 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 4,691-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (100% lower).
The record links to 8 conditions, with Rheumatoid Arthritis appearing as the primary indexed condition, and to 1 intervention - of which Riboflavin is the first listed.
NCT01582880 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01582880 about?
NCT01582880 is a clinical study titled "Use of Cross-linked Donor Corneas as Carriers for the Boston Keratoprosthesis". The purpose of the pilot study is to test the efficacy and safety of riboflavin/Ultraviolet A (UVA) cross-linked human donor corneas as carriers for the Boston Keratoprosthesis (Boston KPro) in patients with higher risk for corneal melting (keratolysis).
What is the current status of trial NCT01582880?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2012-03. Estimated completion is 2014-03.
What conditions does trial NCT01582880 study?
This clinical trial studies the following conditions: Rheumatoid Arthritis, Lupus Erythematosus, Systemic, Autoimmune Diseases, Ocular Cicatricial Pemphigoid, Chemical Injuries.
What interventions are being tested in trial NCT01582880?
The interventions under investigation include: Riboflavin (DRUG).
Who is sponsoring clinical trial NCT01582880?
This trial is sponsored by Joseph B. Ciolino, MD, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01582880 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT01582880's enrollment target sits among peer trials
1 198th of 197 the lowest of 197 other Rheumatoid Arthritis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Rheumatoid Arthritis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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