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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Keratoconus

Intervention / Treatment
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* Procedure: Deep anterior lamellar keratoplasty
* Procedure: Deep anterior lamellar keratoplasty


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DALK using Dehydrated Corneas<br>Corneal transplantation of anterior lamellar grafts from dehydrated corneas. | Procedure: Deep anterior lamellar keratoplasty<br>* Deep anterior lamellar keratoplasty using dehydrated corneas<br>|
| Active Comparator: DALK using Standard Organ Culture Stored Corneas<br>Corneal transplantation of anterior lamellar grafts from standard organ culture stored corneas. | Procedure: Deep anterior lamellar keratoplasty<br>* Deep anterior lamellar keratoplasty using standard organ culture stored corneas<br>|

What is the study measuring?
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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 |