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

Keratoconus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04430244
• Other study ID #: 2020001
• Status: Recruiting
• Phase: N/A
• Start date: June 17, 2020
• Est. completion date: May 2023

Study information

• Verified date: July 2020
• Source: Istituto Internazionale di Ricerca e Formazione in Oftalmologia
• Contact: Massimo Busin, MD
• Phone: +393473448343
• Email: mbusin[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Keratoconus

Intervention

Procedure:
• Deep anterior lamellar keratoplasty
Deep anterior lamellar keratoplasty using dehydrated corneas
• Deep anterior lamellar keratoplasty
Deep anterior lamellar keratoplasty using standard organ culture stored corneas

Locations

Country	Name	City	State
Italy	Ospedali Privati Forlì "Villa Igea"	Forlì	Emilia-Romagna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Internazionale di Ricerca e Formazione in Oftalmologia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Refraction	Measured by manifest refraction	6 and 12 months postoperatively
Other	Adverse Events/Complication	Comparison of total rates of adverse events/complications assessed clinically	up to 12 months postoperatively
Primary	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	Change in astigmatism	Topographic astigmatism (Diopters) is measured using anterior segment optical coherence tomography (CASIA)	Preoperatively; and 6 and 12 months postoperatively
Secondary	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
Secondary	Change in endothelial cell density	Measured using noncontact specular microscopy	Preoperatively; and 6 and 12 months postoperatively
Secondary	Incidence of graft rejection	Clinically assessed during postoperative examinations	6 and 12 months postoperatively
Secondary	Incidence of graft failure	Clinically assessed during postoperative examinations	6 and 12 months postoperatively
Secondary	Corneal donor loss due to preparation	Based on intraoperative assessment of corneas unusable for corneal transplantation	Intraoperative