Bullous KeratopathyNCT07855601
Utilization of Residual Donor Tissue for Regrafting in Bullous Keratopathy After Corneal Transplantation
A study testing Endothelial keratoplasty using residual donor tissue in people with Bullous Keratopathy, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bullous Keratopathy
- What is being tested?
- Endothelial keratoplasty using residual donor tissue
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 17 Oct 2026to 18 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510070
Ting Huang, 8613682205425, qingerdong@126.com
About this study
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
- Being tested
- Endothelial keratoplasty using residual donor tissue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endothelial keratoplasty using residual donor tissueProcedure or surgery
Endothelial keratoplasty using residual donor tissue from previous corneal transplantation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Endothelial keratoplasty using residual donor tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal thickness
Corneal thickness was measured preoperatively and postoperatively using an iVue OCT (OPTOVUE) or another OCT instrument, and the changes were compared.
Measured: 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)
Preoperative and postoperative visual acuity was assessed using the ETDRS chart.
Measured: Preoperatively and at postoperative day 1; at 1 and 2 weeks; and at 1, 2, 3, 6, and 12 months.
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.
Measured: Preoperatively and at postoperative day 1; at 1 and 2 weeks; and at 1, 2, 3, 6, and 12 months.
Corneal edema and opacity
The degree of corneal edema and opacity was examined by slit-lamp microscopy.
Measured: Preoperatively and at postoperative day 1; at 1 and 2 weeks; and at 1, 2, 3, 6, and 12 months.
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.
Measured: At postoperative day 1 and at 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 12 months.
Donor graft detachment
Graft adhesion/apposition was evaluated by slit-lamp microscopy and OCT.
Measured: At postoperative day 1 and at 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 12 months.
Intraocular pressure (IOP)
Preoperative and postoperative IOP was measured using a non-contact tonometer.
Measured: Preoperatively and at 1, 3, 6, and 12 months postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start17 Oct 2026 (estimated)
- Primary completion18 Apr 2028 (estimated)
- Study completion18 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bullous KeratopathyStudies of the same condition, open and under way.
- More trials run by Zhongshan Ophthalmic Center, Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07855601
- Sponsor's protocol ID
- 2026KYPJ038
- Status last verified
- Aug 2026
- First submitted
- 28 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of Residual Donor Tissue for Regrafting in Bullous Keratopathy After Corneal Transplantation
- ClinicalTrials.gov ID
- NCT07855601
- Acronym / sponsor ID
- 2026KYPJ038
- Conditions
- Bullous Keratopathy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 17 Oct 2026 (estimated)
- Primary completion
- 18 Apr 2028 (estimated)
- Study completion
- 18 Oct 2028 (estimated)
- First posted
- 2 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Postoperative corneal thickness | Experimental | Procedure: Endothelial keratoplasty using residual donor tissueTo observe postoperative corneal thickness in patients with bullous keratopathy treated by endothelial keratoplasty using residual donor tissue following previous corneal transplantation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endothelial keratoplasty using residual donor tissueEndothelial keratoplasty using residual donor tissue from previous corneal transplantation | Procedure or surgery | Postoperative corneal thickness |
Primary outcome
Corneal thickness
Time frame: 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.
6 secondary outcomes
Best-corrected visual acuity (BCVA)
Time frame: Preoperatively and at postoperative day 1; at 1 and 2 weeks; and at 1, 2, 3, 6, and 12 months.
Spherical equivalent (SE)
Time frame: Preoperatively and at postoperative day 1; at 1 and 2 weeks; and at 1, 2, 3, 6, and 12 months.
Corneal edema and opacity
Time frame: Preoperatively and at postoperative day 1; at 1 and 2 weeks; and at 1, 2, 3, 6, and 12 months.
Corneal endothelial cell count
Time frame: At postoperative day 1 and at 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 12 months.
Donor graft detachment
Time frame: At postoperative day 1 and at 1 week, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 12 months.
Intraocular pressure (IOP)
Time frame: Preoperatively and at 1, 3, 6, and 12 months postoperatively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endothelial keratoplasty using residual donor tissue in people with Bullous Keratopathy, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaojuan Dong (8613552338060, qingerdong@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corneal thickness (time frame: Preoperatively and at postoperative day 1; at 1 and 2 weeks; and at 1, 2, 3, 6, and 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.