Prospective Study of Deep Anterior Lamellar Keratoplasty Using Acellular Porcine Cornea

Not Applicable

• Conditions: Corneal Transplantation
• Interventions: Procedure: Deep anterior lamellar keratoplasty; Device: Acellular Porcine Cornea; Drug: Tacrolimus eye drops; Drug: Tobradex eyedrops

• Registration Number: NCT03105466
• Lead Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

Brief Summary

The performance of keratoplasty is hampered by the limited availability of donor cornea in many countries, especially in Asia. For this reason, attempts have been made to fabricate artificial substitutes for natural human cornea. So far, all polymeric biomaterials, such as collagen configurations and plastic compression, could mimic the functional optically transparent but failed to replicate the complicate three-dimension microstructure of natural cornea. Therefore, despite some favorable results yielded by polymeric biomaterials, they cannot be suited for long-term use. To overcome these disadvantages, in recent years, porcine cornea appeared specifically attractive for xenotransplantation, because of its accessibility and similarities to natural human cornea. However, xenotransplantation using fresh porcine cornea can occurs hyperacute immune rejection, resulting in graft failure. Such transplant rejection can be substantially lessened by using acellular porcine cornea (APC), which preserves the constructure of natural cornea, whilst having well biocompatibility and low antigenicity. These properties feature APC particularly suitable for high-risk keratoplasty, such as corneal grafting in infectious keratitis.

Use of APC in LK has been shown promise in many preclinical animal studies and initially in human clinic trail. However, to optimize APC biological and biomechanical properties, the strategies for its preparation has evolved extensively over recent years, like various decellularization approaches (e.g. detergents, enzymes, human sera, hypertonic solutions and et al) and additional procedures (e.g. collagen re-crosslinking and repeated frozen-dry). Therefore, in the current study, the investigators analyzed the early surgical outcomes of deep anterior lamellar keratoplasty (DALK) using the APC that was very recently approved by the National Institutes for Food and Drug Control (NIFDC) of China for clinic practice, for management of infective keratitis, including fungal, viral and acanthamoeba keratitis. Here major concern of this study was to clarify the behavior of APC after implantation in participants.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-08-31
• Status Verified: 2017-04
• Study First Submitted QC: 2017-04-07
• Last Update Submitted: 2017-04-07
• Study First Posted: 2017-04-10
• Last Update Posted: 2017-04-10
• Primary Completion: 2020-02
• Study Completion: 2020-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

corneal diseases not involving the endothelial layer

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Exclusion Criteria

• corneal diseases involving the endothelial layer
• allergic to pig tissue
• do not accept xenotransplantation

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acellular porcine cornea group	Acellular Porcine Cornea	Participants with corneal diseases not involving the endothelial layer undergo deep anterior lamellar keratoplasty using acellular porcine cornea
Acellular porcine cornea group	Tobradex eyedrops	Participants with corneal diseases not involving the endothelial layer undergo deep anterior lamellar keratoplasty using acellular porcine cornea
Acellular porcine cornea group	Tacrolimus eye drops	Participants with corneal diseases not involving the endothelial layer undergo deep anterior lamellar keratoplasty using acellular porcine cornea
Acellular porcine cornea group	Deep anterior lamellar keratoplasty	Participants with corneal diseases not involving the endothelial layer undergo deep anterior lamellar keratoplasty using acellular porcine cornea

Primary Outcome Measures

Name	Time	Method
the changes of Best corrected visual acuity	Before surgery, 1-week, 1-month, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year after surgery

Secondary Outcome Measures

Name	Time	Method
the changes of visual contrast sensitivity	Before surgery, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year after surgery
the changes in the transparency of graft	1-week, 1-month, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year after surgery	using Slit lamp microscopic evaluation
The changes in corneal thickness depth	1-week, 1-month, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year after surgery	using anterior segmental OCT
The changes in corneal nerve regeneration	1-month, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year after surgery	using Confocal microscopy
The changes of depression and anxiety status	Before surgery, 1-month, 3-month, 6-month, 1-year, 2-year, 3-year, 4-year after surgery	Using Self-Rating Depression Scale (SDS) and Self-Rating Anxiaty Scale (SAS)

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center, Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China