Accelerated Corneal Collagen Cross LinkingCXLNCT04160338
Assessment of Corneal Endothelium After Collagen Cross Linking
An observational study of Accelerated Corneal Collagen Cross Linking, run by Assiut University.
Trial summary
The aim of this study is to assess the effect of accelerated corneal collagen cross linking on corneal endothelium using the specular microscopy Read more about this study
- Who is it for?
- Ages 16 to 40 years
- Conditions the study is for
- Accelerated Corneal Collagen Cross Linking
- What is being tested?
- specular microscopy
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Dec 2019to Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 16 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: patients who underwent accelerated corneal collagen cross linking
Who may be able to join
- 1. patients with mild to moderate corneal ectasia who are candidates for CXL.
Who cannot join
- patients with advanced corneal ectasia with maximum keratometry readings <56 diopters.
- corneal pachymetry >380um.
- corneal scarring.
- previous corneal surgeries (e.g intrastromal corneal ring segments)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Specular Microscopic Study of Corneal Endothelium After Accelerated Corneal Collagen Cross Linking
The aim of this study is to assess the effect of accelerated corneal collagen cross linking on corneal endothelium using the specular microscopy
Read the detailed description
Keratoconus (KC) is a progressive, non-inflammatory corneal degenerative disease. It is a pathology characterized by a progressive thinning and protrusion of the cornea that ends in a cone-shaped cornea. This results in progressive myopia and irregular astigmatism with associated progressive loss of vision and thus reduced quality of life.Collagen cross-linking (CXL) is a relatively new conservative approach for progressive corneal ectasia. The main indication for CXL is to slow the progression of corneal ectatic diseases, such as keratoconus, pellucid marginal degeneration (PMD), keratoglobus and iatrogenic ectasia.The basic principle of this method is the chemical interaction of ultraviolet A radiation (315-400nm ) and riboflavin to induce covalent bond formation between collagen fibers of the cornea. In this way, the stiffness and rigidity of the cornea are provided.Corneal collagen cross-linking (CXL) was first introduced by Wollensak with an ultraviolet-A (UVA) protocol of 3 medium wave mW/cm2 intensity at 370 nm over an exposure time of 30 minutes (now termed the "Dresden protocol"). Researchers have proposed accelerated CXL (ACXL) protocols, to improve convenience and comfort for patients. These ACXL protocols have the aim of decreasing UVA exposure time by increasing UVA fluency to achieve the same overall total UVA dosage.Despite corneal CXL is a safe and effective procedure with few known side effects .Persistent corneal edema and possible endothelial cell damage have been reported in a few cases after CXL. Based on the extent of endothelial damage, patients may require penetrating keratoplasty.
- Being tested
- specular microscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
specular microscopyDevice
An informed written consent will be obtained from all patients that will be included in this study. Patients in this study will undergo specular microscopic examination of corneal endothelium before CXL procedure.
Patients will be assigned to undergo accelerated (epithelium-off ,transepithelial ) CXL .
Follow up specular microscopy will be done 3 months and 6 months after corneal collagen cross linking procedure .
What is being measured
The primary outcome is the main question the study is designed to answer.
endothelial cell count by specular microscopy.
specular microscopy will be used to assess corneal endothelial cell count after accelerated corneal collagen cross linking
Measured: from preoperatively to 6 months postoperatively
Secondary outcomes (1)
endothelial cell morphology by specular microscopy.
specular microscopy will be used to assess corneal endothelial cell morphology after accelerated corneal collagen cross linking
Measured: from preoperatively to 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study startDec 2019 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Accelerated Corneal Collagen Cross LinkingStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naglaa Mostafa Abdelhafez Abdelmohsen, Assiut University
- Investigators
- Mohamed T Abdelmonem, Professor, Study director, Assiut UneversityHazem A Hazem, lecturer, Study director, Assiut UneversityMahmoud A Abdelsalam, lecturer, Study director, Assiut Uneversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04160338
- Sponsor's protocol ID
- corneal collagen cross linking
- Acronym
- CXL
- Status last verified
- Nov 2019
- First submitted
- 8 Nov 2019
- Last updated
- 13 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Raiskup-Wolf F, Hoyer A, Spoerl E, Pillunat LE. Collagen crosslinking with riboflavin and ultraviolet-A light in keratoconus: long-term results. J Cataract Refract Surg. 2008 May;34(5):796-801. doi: 10.1016/j.jcrs.2007.12.039.
PubMed 18471635Subasinghe SK, Ogbuehi KC, Dias GJ. Current perspectives on corneal collagen crosslinking (CXL). Graefes Arch Clin Exp Ophthalmol. 2018 Aug;256(8):1363-1384. doi: 10.1007/s00417-018-3966-0. Epub 2018 Apr 6.
PubMed 29623463Mencucci R, Marini M, Paladini I, Sarchielli E, Sgambati E, Menchini U, Vannelli GB. Effects of riboflavin/UVA corneal cross-linking on keratocytes and collagen fibres in human cornea. Clin Exp Ophthalmol. 2010 Jan;38(1):49-56. doi: 10.1111/j.1442-9071.2010.02207.x.
PubMed 20447101Wen D, Li Q, Song B, Tu R, Wang Q, O'Brart DPS, McAlinden C, Huang J. Comparison of Standard Versus Accelerated Corneal Collagen Cross-Linking for Keratoconus: A Meta-Analysis. Invest Ophthalmol Vis Sci. 2018 Aug 1;59(10):3920-3931. doi: 10.1167/iovs.18-24656.
PubMed 30073363Kirgiz A, Eliacik M, Yildirim Y. Different accelerated corneal collagen cross-linking treatment modalities in progressive keratoconus. Eye Vis (Lond). 2019 Jun 3;6:16. doi: 10.1186/s40662-019-0141-6. eCollection 2019.
PubMed 31172016Zhang X, Zhao J, Li M, Tian M, Shen Y, Zhou X. Conventional and transepithelial corneal cross-linking for patients with keratoconus. PLoS One. 2018 Apr 5;13(4):e0195105. doi: 10.1371/journal.pone.0195105. eCollection 2018.
PubMed 29621306Vazirani J, Bagga B, Taneja M. Persistent corneal edema after collagen cross-linking for keratoconus. Am J Ophthalmol. 2013 Apr;155(4):775. doi: 10.1016/j.ajo.2013.01.003. No abstract available.
PubMed 23521904Sedaghat M, Bagheri M, Ghavami S, Bamdad S. Changes in corneal topography and biomechanical properties after collagen cross linking for keratoconus: 1-year results. Middle East Afr J Ophthalmol. 2015 Apr-Jun;22(2):212-9. doi: 10.4103/0974-9233.151877.
PubMed 25949080Abdel-Radi M, Abdelmohsen N, Abdelmotaal H, Abd El-Moneim MT. The effect of accelerated pulsed high-fluence corneal cross-linking on corneal endothelium; a prospective specular microscopy study. BMC Ophthalmol. 2023 Apr 18;23(1):163. doi: 10.1186/s12886-023-02912-6.
PubMed 37072730
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Specular Microscopic Study of Corneal Endothelium After Accelerated Corneal Collagen Cross Linking
- ClinicalTrials.gov ID
- NCT04160338
- Acronym / sponsor ID
- CXL / corneal collagen cross linking
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2019 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 13 Nov 2019 (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 aim of this study is to assess the effect of accelerated corneal collagen cross linking on corneal endothelium using the specular microscopy
Detailed description
Keratoconus (KC) is a progressive, non-inflammatory corneal degenerative disease. It is a pathology characterized by a progressive thinning and protrusion of the cornea that ends in a cone-shaped cornea. This results in progressive myopia and irregular astigmatism with associated progressive loss of vision and thus reduced quality of life.Collagen cross-linking (CXL) is a relatively new conservative approach for progressive corneal ectasia. The main indication for CXL is to slow the progression of corneal ectatic diseases, such as keratoconus, pellucid marginal degeneration (PMD), keratoglobus and iatrogenic ectasia.The basic principle of this method is the chemical interaction of ultraviolet A radiation (315-400nm ) and riboflavin to induce covalent bond formation between collagen fibers of the cornea. In this way, the stiffness and rigidity of the cornea are provided.Corneal collagen cross-linking (CXL) was first introduced by Wollensak with an ultraviolet-A (UVA) protocol of 3 medium wave mW/cm2 intensity at 370 nm over an exposure time of 30 minutes (now termed the "Dresden protocol"). Researchers have proposed accelerated CXL (ACXL) protocols, to improve convenience and comfort for patients. These ACXL protocols have the aim of decreasing UVA exposure time by increasing UVA fluency to achieve the same overall total UVA dosage.Despite corneal CXL is a safe and effective procedure with few known side effects .Persistent corneal edema and possible endothelial cell damage have been reported in a few cases after CXL. Based on the extent of endothelial damage, patients may require penetrating keratoplasty.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- patients who underwent accelerated corneal collagen cross linking
Key inclusion criteria (1 listed)
- 1. patients with mild to moderate corneal ectasia who are candidates for CXL.
Key exclusion criteria (4 listed)
- patients with advanced corneal ectasia with maximum keratometry readings <56 diopters.
- corneal pachymetry >380um.
- corneal scarring.
- previous corneal surgeries (e.g intrastromal corneal ring segments)
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 |
|---|---|---|
| specular microscopyAn informed written consent will be obtained from all patients that will be included in this study. Patients in this study will undergo specular microscopic examination of corneal endothelium before CXL procedure. Patients will be assigned to undergo accelerated (epithelium-off ,transepithelial ) CXL . Follow up specular microscopy will be done 3 months and 6 months after corneal collagen cross linking procedure . | Device | – |
Primary outcome
endothelial cell count by specular microscopy.
Time frame: from preoperatively to 6 months postoperatively
specular microscopy will be used to assess corneal endothelial cell count after accelerated corneal collagen cross linking
1 secondary outcome
endothelial cell morphology by specular microscopy.
Time frame: from preoperatively to 6 months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
- Background: PubMed 18471635Raiskup-Wolf F, Hoyer A, Spoerl E, Pillunat LE. Collagen crosslinking with riboflavin and ultraviolet-A light in keratoconus: long-term results. J Cataract Refract Surg. 2008 May;34(5):796-801. doi: 10.1016/j.jcrs.2007.12.039.
- Background: PubMed 29623463Subasinghe SK, Ogbuehi KC, Dias GJ. Current perspectives on corneal collagen crosslinking (CXL). Graefes Arch Clin Exp Ophthalmol. 2018 Aug;256(8):1363-1384. doi: 10.1007/s00417-018-3966-0. Epub 2018 Apr 6.
- Background: PubMed 20447101Mencucci R, Marini M, Paladini I, Sarchielli E, Sgambati E, Menchini U, Vannelli GB. Effects of riboflavin/UVA corneal cross-linking on keratocytes and collagen fibres in human cornea. Clin Exp Ophthalmol. 2010 Jan;38(1):49-56. doi: 10.1111/j.1442-9071.2010.02207.x.
- Background: PubMed 30073363Wen D, Li Q, Song B, Tu R, Wang Q, O'Brart DPS, McAlinden C, Huang J. Comparison of Standard Versus Accelerated Corneal Collagen Cross-Linking for Keratoconus: A Meta-Analysis. Invest Ophthalmol Vis Sci. 2018 Aug 1;59(10):3920-3931. doi: 10.1167/iovs.18-24656.
- Background: PubMed 31172016Kirgiz A, Eliacik M, Yildirim Y. Different accelerated corneal collagen cross-linking treatment modalities in progressive keratoconus. Eye Vis (Lond). 2019 Jun 3;6:16. doi: 10.1186/s40662-019-0141-6. eCollection 2019.
- Background: PubMed 29621306Zhang X, Zhao J, Li M, Tian M, Shen Y, Zhou X. Conventional and transepithelial corneal cross-linking for patients with keratoconus. PLoS One. 2018 Apr 5;13(4):e0195105. doi: 10.1371/journal.pone.0195105. eCollection 2018.
- Background: PubMed 23521904Vazirani J, Bagga B, Taneja M. Persistent corneal edema after collagen cross-linking for keratoconus. Am J Ophthalmol. 2013 Apr;155(4):775. doi: 10.1016/j.ajo.2013.01.003. No abstract available.
- Background: PubMed 25949080Sedaghat M, Bagheri M, Ghavami S, Bamdad S. Changes in corneal topography and biomechanical properties after collagen cross linking for keratoconus: 1-year results. Middle East Afr J Ophthalmol. 2015 Apr-Jun;22(2):212-9. doi: 10.4103/0974-9233.151877.
- Derived from this study: PubMed 37072730Abdel-Radi M, Abdelmohsen N, Abdelmotaal H, Abd El-Moneim MT. The effect of accelerated pulsed high-fluence corneal cross-linking on corneal endothelium; a prospective specular microscopy study. BMC Ophthalmol. 2023 Apr 18;23(1):163. doi: 10.1186/s12886-023-02912-6.
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. This study is not recruiting at the moment.
Mohamed T Abdelmonem, Professor study director
Assiut Uneversity
Hazem A Hazem, lecturer study director
Assiut Uneversity
Mahmoud A Abdelsalam, lecturer study director
Assiut Uneversity
Questions about this trial
What is this clinical trial studying?
An observational study of Accelerated Corneal Collagen Cross Linking, run by Assiut University.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 13 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Naglaa MA Abdelmohsen, M.B.B.CH. (+201095459579, dr.naglaa15@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
endothelial cell count by specular microscopy. (time frame: from preoperatively to 6 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04160338, which also lists 9 linked publications.
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 13 Nov 2019; AzTrials last refreshed its copy on 8 Nov 2026.