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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Xiaojuan Dong
- Telefonní číslo: 8613552338060
- E-mail: qingerdong@126.com
Studijní místa
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Guangdong
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Guangzhou, Guangdong, Čína, 510070
- State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University
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Kontakt:
- Ting Huang
- Telefonní číslo: 8613682205425
- E-mail: qingerdong@126.com
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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 je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Corneal thickness
Časové okno: Preoperatively and at postoperative day 1; at 1 and 2 weeks; and at 1, 2, 3, 6, and 12 months.
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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.
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Best-corrected visual acuity (BCVA)
Časové okno: Preoperatively and at postoperative day 1; at 1 and 2 weeks; and at 1, 2, 3, 6, and 12 months.
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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.
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Spherical equivalent (SE)
Časové okno: Preoperatively and at postoperative day 1; at 1 and 2 weeks; and at 1, 2, 3, 6, and 12 months.
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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.
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Corneal edema and opacity
Časové okno: Preoperatively and at postoperative day 1; at 1 and 2 weeks; and at 1, 2, 3, 6, and 12 months.
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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.
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Corneal endothelial cell count
Časové okno: 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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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
Časové okno: 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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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)
Časové okno: Preoperatively and at 1, 3, 6, and 12 months postoperatively.
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Preoperative and postoperative IOP was measured using a non-contact tonometer. |
Preoperatively and at 1, 3, 6, and 12 months postoperatively.
|
Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
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