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Deep Anterior Lamellar Keratoplasty Using Dehydrated Versus Standard Organ Culture Stored Donor Corneas

Primary Purpose

Keratoconus

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Deep anterior lamellar keratoplasty
Deep anterior lamellar keratoplasty
Sponsored by
Istituto Internazionale di Ricerca e Formazione in Oftalmologia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Keratoconus
  • Surgical candidates for deep anterior lamellar keratoplasty

Exclusion Criteria:

  • 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

Sites / Locations

  • Ospedali Privati Forlì "Villa Igea"Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DALK using Dehydrated Corneas

DALK using Standard Organ Culture Stored Corneas

Arm Description

Corneal transplantation of anterior lamellar grafts from dehydrated corneas.

Corneal transplantation of anterior lamellar grafts from standard organ culture stored corneas.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in astigmatism
Topographic astigmatism (Diopters) is measured using anterior segment optical coherence tomography (CASIA)
Change in Thinnest-point pachymetry
Thinnest-point pachymetry values (um) are measured using anterior segment optical coherence tomography (CASIA)
Change in endothelial cell density
Measured using noncontact specular microscopy
Incidence of graft rejection
Clinically assessed during postoperative examinations
Incidence of graft failure
Clinically assessed during postoperative examinations
Corneal donor loss due to preparation
Based on intraoperative assessment of corneas unusable for corneal transplantation

Full Information

First Posted
June 10, 2020
Last Updated
July 1, 2020
Sponsor
Istituto Internazionale di Ricerca e Formazione in Oftalmologia
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1. Study Identification

Unique Protocol Identification Number
NCT04430244
Brief Title
Deep Anterior Lamellar Keratoplasty Using Dehydrated Versus Standard Organ Culture Stored Donor Corneas
Official Title
Deep Anterior Lamellar Keratoplasty Using Dehydrated Versus Standard Organ Culture Stored Donor Corneas: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 17, 2020 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Internazionale di Ricerca e Formazione in Oftalmologia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
Keratoconus is a common corneal disease characterized by progressive thinning and steepening resulting in significant visual impairment. With improved instrumentation and corneal imaging technology, deep anterior keratoplasty has been recognized as the preferred primary operative technique for cases of keratoconus requiring corneal transplantation. Since corneas preserved through organ culture remain viable only for up to 4 weeks, techniques that can extend storage of corneas have been explored. The objective of this study is to assess the outcomes between deep anterior lamellar keratoplasty using dehydrated versus standard organ culture stored donor corneas.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DALK using Dehydrated Corneas
Arm Type
Experimental
Arm Description
Corneal transplantation of anterior lamellar grafts from dehydrated corneas.
Arm Title
DALK using Standard Organ Culture Stored Corneas
Arm Type
Active Comparator
Arm Description
Corneal transplantation of anterior lamellar grafts from standard organ culture stored corneas.
Intervention Type
Procedure
Intervention Name(s)
Deep anterior lamellar keratoplasty
Intervention Description
Deep anterior lamellar keratoplasty using dehydrated corneas
Intervention Type
Procedure
Intervention Name(s)
Deep anterior lamellar keratoplasty
Intervention Description
Deep anterior lamellar keratoplasty using standard organ culture stored corneas
Primary Outcome Measure Information:
Title
Change in best spectacle-corrected visual acuity
Description
Measured as the difference in best spectacle-corrected visual acuity preoperative, 6 and 12 months postoperatively using ETDRS chart
Time Frame
Preoperatively; and 6 and 12 months postoperatively
Secondary Outcome Measure Information:
Title
Change in astigmatism
Description
Topographic astigmatism (Diopters) is measured using anterior segment optical coherence tomography (CASIA)
Time Frame
Preoperatively; and 6 and 12 months postoperatively
Title
Change in Thinnest-point pachymetry
Description
Thinnest-point pachymetry values (um) are measured using anterior segment optical coherence tomography (CASIA)
Time Frame
Preoperatively; and 6 and 12 months postoperatively
Title
Change in endothelial cell density
Description
Measured using noncontact specular microscopy
Time Frame
Preoperatively; and 6 and 12 months postoperatively
Title
Incidence of graft rejection
Description
Clinically assessed during postoperative examinations
Time Frame
6 and 12 months postoperatively
Title
Incidence of graft failure
Description
Clinically assessed during postoperative examinations
Time Frame
6 and 12 months postoperatively
Title
Corneal donor loss due to preparation
Description
Based on intraoperative assessment of corneas unusable for corneal transplantation
Time Frame
Intraoperative
Other Pre-specified Outcome Measures:
Title
Refraction
Description
Measured by manifest refraction
Time Frame
6 and 12 months postoperatively
Title
Adverse Events/Complication
Description
Comparison of total rates of adverse events/complications assessed clinically
Time Frame
up to 12 months postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Keratoconus Surgical candidates for deep anterior lamellar keratoplasty Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Massimo Busin, MD
Phone
+393473448343
Email
mbusin@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Angeli Christy Yu, MD
Phone
+393663903896
Email
angeliyu@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Massimo Busin, MD
Organizational Affiliation
Università degli Studi di Ferrara
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedali Privati Forlì "Villa Igea"
City
Forlì
State/Province
Emilia-Romagna
ZIP/Postal Code
47122
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Massimo Busin, MD
Email
mbusin@yahoo.com
First Name & Middle Initial & Last Name & Degree
Massimo Busin, MD

12. IPD Sharing Statement

Learn more about this trial

Deep Anterior Lamellar Keratoplasty Using Dehydrated Versus Standard Organ Culture Stored Donor Corneas

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