Utilization of Residual Donor Tissue for Regrafting in Bullous Keratopathy After Corneal Transplantation

NCT07855601 | Not Yet Recruiting

• 1 other identifier: 2026KYPJ038
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative endothelial cell loss following Descemet stripping endothelial keratoplasty (DSEK) remains a well-recognized clinical concern, with long-term follow-up demonstrating approximately 50% reduction in endothelial cell density by 5 years. Compounding this challenge, the critical shortage of corneal donors has severely limited the expansion of corneal transplantation programs in developing countries. In conventional penetrating keratoplasty, only the central 7-mm optical zone is typically harvested, whereas the peripheral donor tissue-whose endothelial cells are believed to exhibit superior viability-is routinely discarded. To address these limitations, we describe the first-in-human use of three residual peripheral donor tissue segments, obtained after conventional keratoplasty, which were combined to perform corneal endothelial transplantation. This innovative approach substantially enhanced donor tissue utilization. Postoperatively, the patient achieved sustained corneal transparency with visual acuity improving from 20/500 to 20/50. Notably, the intersegmental gaps resolved progressively over time. Extending this proof-of-concept case, we subsequently investigated the long-term stability and safety of residual donor tissue endothelial keratoplasty for bullous keratopathy, with comprehensive evaluation of postoperative visual acuity, intraocular pressure, corneal endothelial cell density, and refractive outcomes. This study aims to establish evidence-based support for the safety and efficacy of utilizing residual graft tissue in corneal endothelial transplantation.

Conditions

Bullous Keratopathy

Outcome Measures

Primary Outcomes (1)

• Corneal thickness

  Corneal thickness was measured preoperatively and postoperatively using an iVue OCT (OPTOVUE) or another OCT instrument, and the changes were compared.

  Preoperatively and at postoperative day 1; at 1 and 2 weeks; and at 1, 2, 3, 6, and 12 months.

Secondary Outcomes (6)

• Best-corrected visual acuity (BCVA)

  Preoperatively and at postoperative day 1; at 1 and 2 weeks; and at 1, 2, 3, 6, and 12 months.

• Spherical equivalent (SE)

  Preoperatively and at postoperative day 1; at 1 and 2 weeks; and at 1, 2, 3, 6, and 12 months.

• Corneal edema and opacity

  Preoperatively and at postoperative day 1; at 1 and 2 weeks; and at 1, 2, 3, 6, and 12 months.

• Corneal endothelial cell count

  At postoperative day 1 and at 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 12 months.

• Donor graft detachment

  At postoperative day 1 and at 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 12 months.

Study Arms (1)

Postoperative corneal thickness

EXPERIMENTAL

To observe postoperative corneal thickness in patients with bullous keratopathy treated by endothelial keratoplasty using residual donor tissue following previous corneal transplantation.

Procedure: Endothelial keratoplasty using residual donor tissue

Interventions

Endothelial keratoplasty using residual donor tissue PROCEDURE

Endothelial keratoplasty using residual donor tissue from previous corneal transplantation

Postoperative corneal thickness

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with bullous keratopathy of various etiologies, with a corneal thickness of ≥650 μm, refractory to medical treatment.
• Aged ≥18 years.
• The subject or their legally authorized guardian voluntarily consents to participate in this study and signs the informed consent form, with good compliance and willingness to attend follow-up visits.

You may not qualify if:

• Loss of vision in the fellow eye.
• Corneal or ocular surface infection within 30 days prior to enrollment.
• Severe dry eye, with Schirmer's test \< 5 mm.
• Concurrent diseases that may affect the transplantation or prognosis, such as advanced glaucoma or retinal diseases.
• Ocular surface malignancy.
• Severe cicatrizing ocular disease; conjunctival scarring with fornix shortening.
• Recent HbA1c \> 6.5%, or uncontrolled diabetes mellitus.
• Severe impairment of vital organs, including the heart, liver, or kidneys.
• Severe hematologic or endocrine disorders, or a history of such disorders.
• Active autoimmune disease.
• Current signs of infection, including fever or ongoing antibiotic therapy.
• Psychiatric disorders.
• Pregnant or lactating women, or women planning pregnancy within 2 years.
• Participation in other clinical studies or trials within 3 months.
• Subjects who lack compliance with the study or the capacity to sign the informed consent form.

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

Study Sites (1)

State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510070, China

Location

Central Study Contacts

Xiaojuan Dong

CONTACT

8613552338060; qingerdong@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2026
• First Posted: October 2, 2026
• Study Start (Estimated): October 17, 2026
• Primary Completion (Estimated): April 18, 2028
• Study Completion (Estimated): October 18, 2028
• Last Updated: October 2, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)