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

28. september 2026 opdateret af: Zhongshan Ophthalmic Center, Sun Yat-sen University

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

20

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510070
        • State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Postoperative corneal thickness

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

Endothelial keratoplasty using residual donor tissue from previous corneal transplantation

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Corneal thickness
Tidsramme: Preoperatively and at postoperative day 1; at 1 and 2 weeks; and at 1, 2, 3, 6, and 12 months.

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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Best-corrected visual acuity (BCVA)
Tidsramme: Preoperatively and at postoperative day 1; at 1 and 2 weeks; and at 1, 2, 3, 6, and 12 months.

Preoperative and postoperative visual acuity was assessed using the ETDRS chart.
Preoperatively and at postoperative day 1; at 1 and 2 weeks; and at 1, 2, 3, 6, and 12 months.
Spherical equivalent (SE)
Tidsramme: Preoperatively and at postoperative day 1; at 1 and 2 weeks; and at 1, 2, 3, 6, and 12 months.

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.
Preoperatively and at postoperative day 1; at 1 and 2 weeks; and at 1, 2, 3, 6, and 12 months.
Corneal edema and opacity
Tidsramme: Preoperatively and at postoperative day 1; at 1 and 2 weeks; and at 1, 2, 3, 6, and 12 months.

The degree of corneal edema and opacity was examined by slit-lamp microscopy.
Preoperatively and at postoperative day 1; at 1 and 2 weeks; and at 1, 2, 3, 6, and 12 months.
Corneal endothelial cell count
Tidsramme: At postoperative day 1 and at 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 12 months.

Postoperative corneal endothelial cell density was measured using laser confocal microscopy (Heidelberg Engineering, Germany) or a corneal endothelial specular microscope, and changes were compared.
At postoperative day 1 and at 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 12 months.
Donor graft detachment
Tidsramme: At postoperative day 1 and at 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 12 months.

Graft adhesion/apposition was evaluated by slit-lamp microscopy and OCT.
At postoperative day 1 and at 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 12 months.
Intraocular pressure (IOP)
Tidsramme: Preoperatively and at 1, 3, 6, and 12 months postoperatively.

Preoperative and postoperative IOP was measured using a non-contact tonometer.
Preoperatively and at 1, 3, 6, and 12 months postoperatively.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

17. oktober 2026

Primær færdiggørelse (Anslået)

18. april 2028

Studieafslutning (Anslået)

18. oktober 2028

Datoer for studieregistrering

Først indsendt

28. september 2026

Først indsendt, der opfyldte QC-kriterier

28. september 2026

Først opslået (Faktiske)

2. oktober 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. september 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 2026KYPJ038

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