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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorZhongshan Ophthalmic Center, Sun Yat-sen University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Endothelial keratoplasty using residual donor tissue

    Procedure/Surgery

    Endothelial keratoplasty using residual donor tissue from previous corneal transplantation

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Postoperative corneal thicknessExperimental treatment 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Best-corrected visual acuity (BCVA)

Preoperative and postoperative visual acuity was assessed using the ETDRS chart.

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

Spherical equivalent (SE)

Preoperative and postoperative SE was measured using a phoropter and an autorefractor, and differences before and after surgery as well as between the two groups were compared.

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

Corneal edema and opacity

The degree of corneal edema and opacity was examined by slit-lamp microscopy.

Time frame
Preoperatively and at postoperative day 1; at 1 and 2 weeks; and at 1, 2, 3, 6, and 12 months.
4

Corneal endothelial cell count

Postoperative corneal endothelial cell density was measured using laser confocal microscopy (Heidelberg Engineering, Germany) or a corneal endothelial specular microscope, and changes were compared.

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

Other outcomes

Sponsors and contacts

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