Utilization of Residual Donor Tissue for Regrafting in Bullous Keratopathy After Corneal Transplantation
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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Xiaojuan Dong
- Numer telefonu: 8613552338060
- E-mail: qingerdong@126.com
Lokalizacje studiów
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Guangdong
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Guangzhou, Guangdong, Chiny, 510070
- State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University
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Kontakt:
- Ting Huang
- Numer telefonu: 8613682205425
- E-mail: qingerdong@126.com
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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. |
Endothelial keratoplasty using residual donor tissue from previous corneal transplantation |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Corneal thickness
Ramy czasowe: 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.
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Best-corrected visual acuity (BCVA)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.
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Donor graft detachment
Ramy czasowe: 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.
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Intraocular pressure (IOP)
Ramy czasowe: 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.
|
Współpracownicy i badacze
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- 2026KYPJ038
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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