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

Deep Anterior Lamellar Keratoplasty Using Dehydrated Versus Standard Organ Culture Stored Donor Corneas: A Randomized Controlled Trial

The objective of this study is to assess the outcomes between deep anterior lamellar keratoplasty using dehydrated versus standard organ culture stored donor corneas.

Study Overview

• Status: Recruiting
• Conditions: Keratoconus
• Intervention / Treatment: Procedure: Deep anterior lamellar keratoplasty; Procedure: Deep anterior lamellar keratoplasty

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Massimo Busin, MD; Phone Number: +393473448343; Email: mbusin@yahoo.com
• Study Contact Backup: Name: Angeli Christy Yu, MD; Phone Number: +393663903896; Email: angeliyu@gmail.com

Study Locations

• Italy
  • Emilia-Romagna
    • Forlì, Emilia-Romagna, Italy, 47122
      • Recruiting
      • Ospedali Privati Forlì "Villa Igea"
      • Contact: Massimo Busin, MD; Email: mbusin@yahoo.com
      • Principal Investigator: Massimo Busin, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: DALK using Dehydrated Corneas; Corneal transplantation of anterior lamellar grafts from dehydrated corneas.	Procedure: Deep anterior lamellar keratoplasty; Deep anterior lamellar keratoplasty using dehydrated corneas; Procedure: Deep anterior lamellar keratoplasty; Deep anterior lamellar keratoplasty using standard organ culture stored corneas
ACTIVE_COMPARATOR: DALK using Standard Organ Culture Stored Corneas; Corneal transplantation of anterior lamellar grafts from standard organ culture stored corneas.	Procedure: Deep anterior lamellar keratoplasty; Deep anterior lamellar keratoplasty using dehydrated corneas; Procedure: Deep anterior lamellar keratoplasty; Deep anterior lamellar keratoplasty using standard organ culture stored corneas

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in astigmatism	Topographic astigmatism (Diopters) is measured using anterior segment optical coherence tomography (CASIA)	Preoperatively; and 6 and 12 months postoperatively
Change in Thinnest-point pachymetry	Thinnest-point pachymetry values (um) are measured using anterior segment optical coherence tomography (CASIA)	Preoperatively; and 6 and 12 months postoperatively
Change in endothelial cell density	Measured using noncontact specular microscopy	Preoperatively; and 6 and 12 months postoperatively
Incidence of graft rejection	Clinically assessed during postoperative examinations	6 and 12 months postoperatively
Incidence of graft failure	Clinically assessed during postoperative examinations	6 and 12 months postoperatively
Corneal donor loss due to preparation	Based on intraoperative assessment of corneas unusable for corneal transplantation	Intraoperative

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Refraction	Measured by manifest refraction	6 and 12 months postoperatively
Adverse Events/Complication	Comparison of total rates of adverse events/complications assessed clinically	up to 12 months postoperatively

Collaborators and Investigators

• Sponsor: Istituto Internazionale di Ricerca e Formazione in Oftalmologia
• Investigators: Principal Investigator: Massimo Busin, MD, Università degli Studi di Ferrara

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 17, 2020
• Primary Completion (ANTICIPATED): May 1, 2023
• Study Completion (ANTICIPATED): May 1, 2023

Study Registration Dates

• First Submitted: June 10, 2020
• First Submitted That Met QC Criteria: June 10, 2020
• First Posted (ACTUAL): June 12, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 7, 2020
• Last Update Submitted That Met QC Criteria: July 1, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Keratoconus
• Other Study ID Numbers: 2020001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No