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

Not Applicable

• Conditions: Keratoconus
• Interventions: Procedure: Deep anterior lamellar keratoplasty

• Registration Number: NCT04430244
• Lead Sponsor: Istituto Internazionale di Ricerca e Formazione in Oftalmologia

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.

Study Timeline

• Study First Submitted: 2020-06-10
• Study First Submitted QC: 2020-06-10
• Study First Posted: 2020-06-12
• Study Start: 2020-06-17
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-01
• Last Update Posted: 2020-07-07
• Primary Completion: 2023-05
• Study Completion: 2023-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DALK using Standard Organ Culture Stored Corneas	Deep anterior lamellar keratoplasty	Corneal transplantation of anterior lamellar grafts from standard organ culture stored corneas.
DALK using Dehydrated Corneas	Deep anterior lamellar keratoplasty	Corneal transplantation of anterior lamellar grafts from dehydrated corneas.

Primary Outcome Measures

Name	Time	Method
Change in best spectacle-corrected visual acuity	Preoperatively; and 6 and 12 months postoperatively	Measured as the difference in best spectacle-corrected visual acuity preoperative, 6 and 12 months postoperatively using ETDRS chart

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ospedali Privati Forlì "Villa Igea"; 🇮🇹 Forlì, Emilia-Romagna, Italy