Deep Anterior Lamellar Keratoplasty Using Dehydrated Versus Standard Organ Culture Stored Donor Corneas
1 other identifier
interventional
60
1 country
1
Brief Summary
The objective of this study is to assess the outcomes between deep anterior lamellar keratoplasty using dehydrated versus standard organ culture stored donor corneas.
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 Jun 2020
Typical duration for not_applicable
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
June 10, 2020
CompletedFirst Posted
Study publicly available on registry
June 12, 2020
CompletedStudy Start
First participant enrolled
June 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2023
CompletedJuly 7, 2020
July 1, 2020
2.9 years
June 10, 2020
July 1, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Change in best spectacle-corrected visual acuity
Measured as the difference in best spectacle-corrected visual acuity preoperative, 6 and 12 months postoperatively using ETDRS chart
Preoperatively; and 6 and 12 months postoperatively
Secondary Outcomes (6)
Change in astigmatism
Preoperatively; and 6 and 12 months postoperatively
Change in Thinnest-point pachymetry
Preoperatively; and 6 and 12 months postoperatively
Change in endothelial cell density
Preoperatively; and 6 and 12 months postoperatively
Incidence of graft rejection
6 and 12 months postoperatively
Incidence of graft failure
6 and 12 months postoperatively
- +1 more secondary outcomes
Other Outcomes (2)
Refraction
6 and 12 months postoperatively
Adverse Events/Complication
up to 12 months postoperatively
Study Arms (2)
DALK using Dehydrated Corneas
EXPERIMENTALCorneal transplantation of anterior lamellar grafts from dehydrated corneas.
DALK using Standard Organ Culture Stored Corneas
ACTIVE COMPARATORCorneal transplantation of anterior lamellar grafts from standard organ culture stored corneas.
Interventions
Deep anterior lamellar keratoplasty using dehydrated corneas
Eligibility Criteria
You may qualify if:
- Keratoconus
- Surgical candidates for deep anterior lamellar keratoplasty
You may not qualify if:
- Ocular comorbidities other than cataract (ie. visual significant optic nerve or macular disease)
- Previous corneal transplantations or other ocular surgeries except uncomplicated cataract surgery
- Inability to comply with study protocol or participate in follow-up visits
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ospedali Privati Forlì "Villa Igea"
Forlì, Emilia-Romagna, 47122, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Massimo Busin, MD
Università degli Studi di Ferrara
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2020
First Posted
June 12, 2020
Study Start
June 17, 2020
Primary Completion
May 1, 2023
Study Completion
May 1, 2023
Last Updated
July 7, 2020
Record last verified: 2020-07