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

Istituto Internazionale di Ricerca e Formazione in Oftalmologia

Status: Unknown

Conditions: Keratoconus

Treatments: Procedure: Deep anterior lamellar keratoplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT04430244

2020001

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

60 participants in 2 patient groups

DALK using Dehydrated Corneas

Experimental group

Description:

Corneal transplantation of anterior lamellar grafts from dehydrated corneas.

Treatment:

Procedure: Deep anterior lamellar keratoplasty

Procedure: Deep anterior lamellar keratoplasty

DALK using Standard Organ Culture Stored Corneas

Active Comparator group

Description:

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

Treatment:

Procedure: Deep anterior lamellar keratoplasty

Procedure: Deep anterior lamellar keratoplasty