KeratoconusNCT05905978
Donors Predisposed by Corneal Collagen Cross-linking in Deep Lamellar Keratoplasty for the Patients With Keratoconus
A study testing Corneal donors predisposed by CXL and Corneal donors stored in corneal storage media in people with Keratoconus, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial summary
The Study was designed as a randomized controlled study with the following objectives: To investigate whether use of donors predisposed by corneal collagen cross-linking (CXL) reduced myopic refractive errors for keratoconic eyes after Deep anterior lamellar keratoplasty (DALK). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Keratoconus
- What is being tested?
- Corneal donors predisposed by CXL and Corneal donors stored in corneal storage media
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- Jun 2023to Jul 2027
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.The best corrected visual quality of frame glasses is less than 0.3，2.The best corrected visual quality of rigid gas permeable contact lens (RGPCL) is less than 0.5/ RGPCL intolerance，3.The anterior corneal surface curvature >55D，4.The thinnest corneal thickness is less than 400 μm. One of the above four items is met
- Patients must be willing and able to return for scheduled follow-up examinations for 36 months after surgery
- Ages：over 18 Years
Who cannot join
- History of intraocular surgery
- Severe dry eye
- Severe eyelid and conjunctival scar
- Loss of vision in contralateral eye
- Pregnant and lactating women
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
Zhongshan Ophthalmic Center, Sun Yat-Sen University
Guangzhou, Guangdong, 510070
Ling Jin, 86-20-87334687, lingjin41@yahoo.com
About this study
Official title: Effectiveness and Safety of Donors Predisposed by Corneal Collagen Cross-linking in Deep Lamellar Keratoplasty for Treating the Patients With Keratoconus，A Randomized Controlled Trial.
The Study was designed as a randomized controlled study with the following objectives:
To investigate whether use of donors predisposed by corneal collagen cross-linking (CXL) reduced myopic refractive errors for keratoconic eyes after Deep anterior lamellar keratoplasty (DALK).
Overall 70 patients are planned to recruit., the patients were assigned to CXL graft group, in which corneal donors predisposed by CXL were used, or the conventional graft group, in which corneal donors stored in corneal storage media were used. The patients will be followed-up for 24 months.
Read the detailed description
Keratoconus is a progressive ecstatic corneal disease characterized by forward bulging of the cornea, thinning of the corneal stroma, and irregular astigmatism. Corneal transplantation is necessary for patients with advanced keratoconus when spectacles and contact lens are inadequate for visual correction. Deep anterior lamellar keratoplasty is a conventional procedure for the treatment of keratoconus. However, DALK itself frequently causes abnormality of refraction, such as high degrees of astigmatism owing to irregular corneal surface for keratoconic eyes. Possible mechanisms of this progressive astigmatism include the recurrence of keratoconus in the grafts, progressive corneal thinning of the host cornea, or progressive misalignment of the graft- host interface over time, which prevents the achievement of satisfactory vision.
Corneal collagen cross-linking is believed to have the ability to halt or decrease the progression of keratoconus. CXL treats keratoconus by strengthening corneal stromal collagen bonds with riboflavin activated by ultraviolet A (UVA), and is now a first-line treatment for progressive keratoconus. In this randomized controlled trial, we performed CXL on corneal donor tissues with the aim of achieving corneal stromal stiffening, thereafter DALK was conducted for the patients with advanced keratoconus using the tissues predisposed by CXL. The goal of this study is evaluating whether the strengthening grafts could reduce postoperative myopic refractive errors or arrest the progression of keratoconus for the patients with DALK.
- Conditions
- Keratoconus
- Being tested
- Corneal donors predisposed by CXL, Corneal donors stored in corneal storage media
- Keywords
- Corneal collagen cross-linking, Deep lamellar keratoplasty, Keratoconus
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corneal donors predisposed by CXLProcedure or surgery
Corneal donors predisposed by CXL and DALK procedure was conducted in patients
Corneal donors stored in corneal storage mediaProcedure or surgery
Corneal donors stored in corneal storage media and DALK procedure was conducted in patients
| Study group | Role | What they receive |
|---|---|---|
| CXL graft group | Experimental | Corneal donors predisposed by CXL were used and the conventional DALK procedure was conducted in patients Receives: Procedure: Corneal donors predisposed by CXL |
| Conventional graft group | Active comparator | Corneal donors stored in corneal storage media were used and the conventional DALK procedure was conducted in patients Receives: Procedure: Corneal donors stored in corneal storage media |
What is being measured
The primary outcome is the main question the study is designed to answer.
Simulated keratometry
Simulated keratometry measured by topography
Measured: up to 36 months
Secondary outcomes (7)
Uncorrected distance visual acuity（UDVA）
UDVA (by using Snellen acuity charts) before surgery, at 1 week, 1, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months after surgery
Measured: 36 months
Corrected distance visual acuity （CDVA）
CDVA (by using Snellen acuity charts) before surgery, at 1 week, 1, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months after surgery
Measured: 36 months
Spherical equivalent (SE)
SE will be detected by combined optometry and phoroptor refractometer before surgery, at 1 week, 1, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months after surgery
Measured: 36 months
Manifest cylinder
Manifest cylinder will be detected by topography before surgery, at 1 week, 1, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months after surgery
Measured: 36 months
Corneal thickness
Corneal thickness of the thinnest area will be detected by Optical Coherence tomography before surgery, at 1 week, 1, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months after surgery
Measured: 36 months
Corneal endothelium cells
Corneal endothelium cells will be detected by confocal microscopy before surgery, at 1 week, 1, 3, 6, 9, 12, 15, 18, 21, 24 ,30 and 36 months after surgery
Measured: 36 months
Intraocular pressure
Intraocular pressure was measured by non-contact tonometer before surgery, at 1 week, 1, 3, 6, 9, 12, 15, 18, 21, 24,30 and 36 months after surgery
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study startJun 2023 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeratoconusStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05905978
- Sponsor's protocol ID
- 2020KYPJ163
- Status last verified
- May 2023
- First submitted
- 2 Jun 2023
- Last updated
- 15 Jun 2023
- 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 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Donors Predisposed by Corneal Collagen Cross-linking in Deep Lamellar Keratoplasty for Treating the Patients With Keratoconus，A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05905978
- Acronym / sponsor ID
- 2020KYPJ163
- Conditions
- Keratoconus
- Keywords
- Corneal collagen cross-linking, Deep lamellar keratoplasty, Keratoconus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Jun 2023 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 15 Jun 2023 (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.
The Study was designed as a randomized controlled study with the following objectives:
To investigate whether use of donors predisposed by corneal collagen cross-linking (CXL) reduced myopic refractive errors for keratoconic eyes after Deep anterior lamellar keratoplasty (DALK).
Overall 70 patients are planned to recruit., the patients were assigned to CXL graft group, in which corneal donors predisposed by CXL were used, or the conventional graft group, in which corneal donors stored in corneal storage media were used. The patients will be followed-up for 24 months.
Detailed description
Keratoconus is a progressive ecstatic corneal disease characterized by forward bulging of the cornea, thinning of the corneal stroma, and irregular astigmatism. Corneal transplantation is necessary for patients with advanced keratoconus when spectacles and contact lens are inadequate for visual correction. Deep anterior lamellar keratoplasty is a conventional procedure for the treatment of keratoconus. However, DALK itself frequently causes abnormality of refraction, such as high degrees of astigmatism owing to irregular corneal surface for keratoconic eyes. Possible mechanisms of this progressive astigmatism include the recurrence of keratoconus in the grafts, progressive corneal thinning of the host cornea, or progressive misalignment of the graft- host interface over time, which prevents the achievement of satisfactory vision.
Corneal collagen cross-linking is believed to have the ability to halt or decrease the progression of keratoconus. CXL treats keratoconus by strengthening corneal stromal collagen bonds with riboflavin activated by ultraviolet A (UVA), and is now a first-line treatment for progressive keratoconus. In this randomized controlled trial, we performed CXL on corneal donor tissues with the aim of achieving corneal stromal stiffening, thereafter DALK was conducted for the patients with advanced keratoconus using the tissues predisposed by CXL. The goal of this study is evaluating whether the strengthening grafts could reduce postoperative myopic refractive errors or arrest the progression of keratoconus for the patients with DALK.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CXL graft group | Experimental | Procedure: Corneal donors predisposed by CXLCorneal donors predisposed by CXL were used and the conventional DALK procedure was conducted in patients |
| Conventional graft group | Active comparator | Procedure: Corneal donors stored in corneal storage mediaCorneal donors stored in corneal storage media were used and the conventional DALK procedure was conducted in patients |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1.The best corrected visual quality of frame glasses is less than 0.3，2.The best corrected visual quality of rigid gas permeable contact lens (RGPCL) is less than 0.5/ RGPCL intolerance，3.The anterior corneal surface curvature >55D，4.The thinnest corneal thickness is less than 400 μm. One of the above four items is met
- Patients must be willing and able to return for scheduled follow-up examinations for 36 months after surgery
- Ages：over 18 Years
Key exclusion criteria (5 listed)
- History of intraocular surgery
- Severe dry eye
- Severe eyelid and conjunctival scar
- Loss of vision in contralateral eye
- Pregnant and lactating women
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 |
|---|---|---|
| Corneal donors predisposed by CXLCorneal donors predisposed by CXL and DALK procedure was conducted in patients | Procedure or surgery | CXL graft group |
| Corneal donors stored in corneal storage mediaCorneal donors stored in corneal storage media and DALK procedure was conducted in patients | Procedure or surgery | Conventional graft group |
Primary outcome
Simulated keratometry
Time frame: up to 36 months
Simulated keratometry measured by topography
7 secondary outcomes
Uncorrected distance visual acuity（UDVA）
Time frame: 36 months
Corrected distance visual acuity （CDVA）
Time frame: 36 months
Spherical equivalent (SE)
Time frame: 36 months
Manifest cylinder
Time frame: 36 months
Corneal thickness
Time frame: 36 months
Corneal endothelium cells
Time frame: 36 months
Intraocular pressure
Time frame: 36 months
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 15 Jun 2023.
- 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 Corneal donors predisposed by CXL and Corneal donors stored in corneal storage media in people with Keratoconus, 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 5 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 15 Jun 2023. 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 Ting Huang, MD, PHD (86-13682205425, thuang@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Simulated keratometry (time frame: up to 36 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 15 Jun 2023.