Donors Predisposed by Corneal Collagen Cross-linking in Deep Lamellar Keratoplasty for the Patients With Keratoconus
NCT ID: NCT05905978
Last Updated: 2023-06-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
70 participants
INTERVENTIONAL
2023-06-30
2027-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy of Customized Corneal Cross-linking vs. Standard Corneal Cross-linking
NCT04532788
Simultaneous Corneal Wavefront-Guided Trans-PRK and Corneal Collagen Crosslinking After ICRS Implantation for Moderate Keratoconus
NCT03355430
Refractive Corneal Cross-linking for Progressive Keratoconus
NCT03531047
Deep Anterior Lamellar Keratoplasty (DALK) Using Acellular Corneal Tissue Promotes Corneal Allograft Survival in High Risk Patients
NCT01021046
Prospective Study of Deep Anterior Lamellar Keratoplasty Using Acellular Porcine Cornea
NCT03105466
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CXL graft group
Corneal donors predisposed by CXL were used and the conventional DALK procedure was conducted in patients
Corneal donors predisposed by CXL
Corneal donors predisposed by CXL and DALK procedure was conducted in patients
Conventional graft group
Corneal donors stored in corneal storage media were used and the conventional DALK procedure was conducted in patients
Corneal donors stored in corneal storage media
Corneal donors stored in corneal storage media and DALK procedure was conducted in patients
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Corneal donors predisposed by CXL
Corneal donors predisposed by CXL and DALK procedure was conducted in patients
Corneal donors stored in corneal storage media
Corneal donors stored in corneal storage media and DALK procedure was conducted in patients
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients must be willing and able to return for scheduled follow-up examinations for 36 months after surgery
* Ages：over 18 Years
Exclusion Criteria
* Severe dry eye
* Severe eyelid and conjunctival scar
* Loss of vision in contralateral eye
* Pregnant and lactating women
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Zhongshan Ophthalmic Center, Sun Yat-sen University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Zhongshan Ophthalmic Center, Sun Yat-Sen University
Guangzhou, Guangdong, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2020KYPJ163
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.