Corneal Ectasia of Both EyesNCT05717517
Collagen Cross-linking Clinical and Oct Study
An observational study of Corneal Ectasia of Both Eyes, run by Assiut University.
Trial summary
1. Assessment of corneal changes in AS-OCT after collagen cross-linking (corneal thickness and demarcation line). 2. Assessment of the effect of collagen cross-linking on best-corrected visual acuity Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Corneal Ectasia of Both Eyes
- What is being tested?
- anterior segment oct
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Aug 2023to Mar 2024
- 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 18 to 50 years
- All sexes
- Adult
Study population: patients who underwent classic corneal collagen cross-linking
Who may be able to join
- patients with e corneal ectasia who are candidates for CXL.
Who cannot join
- patients with other corneal diseases not treated by collagen cross-linking
- corneal scarring.
- previous corneal surgeries (e.g intrastromal corneal ring segments)
Trial locations and contacts
No sites are listed yet.
mohammed saad, professor contact
About this study
Official title: Corneal Changes After Collagen Cross-linking ; Clinical and Oct Study
- Assessment of corneal changes in AS-OCT after collagen cross-linking (corneal thickness and demarcation line).
- Assessment of the effect of collagen cross-linking on best-corrected visual acuity
Read the detailed description
Cross-linking of collagen refers to the ability of collagen fibrils to form strong chemical bonds with adjacent fibrils. In the cornea, collagen cross-linking occurs naturally with aging due to an oxidative deamination reaction that takes place within the end chains of the collagen. It has been hypothesized that this natural cross-linkage of collagen explains why keratectasia (corneal ectasia) often progresses most rapidly in adolescence or early adulthood but tends to stabilize in patients after middle-age.
Human studies of UV-induced corneal cross-linking began in 2003 in Dresden, and early results were promising. The initial pilot study enrolled 16 patients with rapidly progressing keratoconus and all of the patients stopped progressing after treatment. Additionally, 70% had flattening of their steep anterior corneal curvatures (decreases in average and maximum keratometric values), and 65% had an improvement in visual acuity. There were no reported complications.
Per the typical cross-linking protocol, 0.1% riboflavin solution with 20% dextran is added to the de-epithelialized cornea and then photoactivated with UV-A light at 365 nm with irradiance of 3 mW/cm2 for 30 minutes. The cornea is de-epithelialized to allow adequate penetration of riboflavin into the corneal stroma. Riboflavin acts as photosensitizer; it creates free radicals, forms new molecular crosslinks, and ultimately increases the cornea's mechanical strength.
Collagen cross-linking experienced a rapid transition from laboratory procedure to clinical intervention because of the method's apparent safety and broad array of potential applications. One such clinical application is the treatment of keratoconus which is a degenerative disorder of the eye associated with thinning and subsequent bulging of the cornea, causing poor vision. Collagen cross-linking stops the progression of keratoconus in patients with mild disease, presumably by strengthening the cornea and preventing further bulging.
Collagen cross-linking has also been used successfully in the treatment of pellucid marginal degeneration and to treat iatrogenic (postoperative) ectasia. Studies have shown that CXL causes a reduction in corneal edema and thickness with improvement in visual acuity in patients with bullous keratopathy due to different causes. However, these changes last for only about six months and due to this transient effect, CXL may only have a palliative role, if at all, for now.
The effect of cross linking can be assessed postoperatively clinically and also by some devices such as Ocular Response Analyzer (Reichert Inc., Buffalo, NY, USA). The depth of treatment can be measured by the demarcation line, which usually appears at 10 to 14 days after CXL and can be monitored using corneal topography and tomography.
Optical coherence tomography (OCT) is a modality that uses low-coherence interferometry to enable non-contact, in vivo imaging of ocular structures. Since its introduction, OCT imaging has become a key part of clinical evaluation of the cornea, and the anterior eye segment.
As improvements to the technology have increased, e.g. the speed and resolution of the images captured, the impact of anterior segment OCT (AS OCT) imaging on clinical practice, has been rapidly increasing and the clinical potential of the technique in evaluating the cornea had been realized. Specific to the cornea, AS OCT now allows us to image corneal layers and structures in greater detail i.e. epithelium, Bowman's layer, stroma, Descemet membrane and endothelium.
The AS OCT is extremely useful in studying anterior segment pathology through an edematous cornea such as in Descemet membrane detachments , corneal stroma itself and corneal infiltrates secondary to infections.
AS OCT is also useful in assessing changes in cornea postoperative including corneal changes after cross linking. The most widely reported change seen on cross-sectional OCT following CXL has been the appearance of a 'demarcation' line within the corneal stroma. This line has been postulated to represent the depth of the CXL treatment, separating the treated anterior stroma and untreated posterior stroma. The demarcation line is hyper-reflective when viewed with OCT, Scheimpflug imaging and on slit lamp biomicroscopy. OCT provides the ability to measure the depth of the demarcation line and has been used as an important outcome parameter when comparing various CXL protocols. The demarcation line usually fades by three months and, in some corneas, is replaced with faint, irregular, hyper-reflective lines in the deep stroma.
Other changes that can be noted on OCT images following CXL include increased reflectivity of the treated stroma, and the appearance of fainter, secondary stromal demarcation lines.
- Conditions
- Corneal Ectasia of Both Eyes
- Being tested
- anterior segment oct
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anterior segment octDevice
Also called collagen cross linking
ant segment oct before and after corneal collagen cross-linking
What is being measured
The primary outcome is the main question the study is designed to answer.
corneal thickness after collagen cross linking OCT study
corneal thickness measurement in mm
Measured: 12 months
Secondary outcomes (1)
corneal demarcation line after collagen cross linking OCT study
measurement of the depth of demarcation line from tear film in mm
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study startAug 2023 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Corneal Ectasia of Both EyesStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Aly, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05717517
- Sponsor's protocol ID
- ant seg oct in cross linking
- Status last verified
- Jul 2023
- First submitted
- 19 Oct 2021
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wollensak G, Spoerl E, Seiler T. Stress-strain measurements of human and porcine corneas after riboflavin-ultraviolet-A-induced cross-linking. J Cataract Refract Surg. 2003 Sep;29(9):1780-5. doi: 10.1016/s0886-3350(03)00407-3.
PubMed 14522301Raiskup F, Spoerl E. Corneal crosslinking with riboflavin and ultraviolet A. I. Principles. Ocul Surf. 2013 Apr;11(2):65-74. doi: 10.1016/j.jtos.2013.01.002. Epub 2013 Jan 24.
PubMed 23583042Brummer G, Littlechild S, McCall S, Zhang Y, Conrad GW. The role of nonenzymatic glycation and carbonyls in collagen cross-linking for the treatment of keratoconus. Invest Ophthalmol Vis Sci. 2011 Aug 11;52(9):6363-9. doi: 10.1167/iovs.11-7585.
PubMed 21724915Raiskup F, Terai N, Velika V, Sporl E. [Corneal Cross-Linking with Riboflavin and UVA in Keratoconus]. Klin Monbl Augenheilkd. 2016 Aug;233(8):938-44. doi: 10.1055/s-0042-102060. Epub 2016 Apr 7. German.
PubMed 27055493
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corneal Changes After Collagen Cross-linking ; Clinical and Oct Study
- ClinicalTrials.gov ID
- NCT05717517
- Acronym / sponsor ID
- ant seg oct in cross linking
- Conditions
- Corneal Ectasia of Both Eyes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Aug 2023 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 8 Feb 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.
- Assessment of corneal changes in AS-OCT after collagen cross-linking (corneal thickness and demarcation line).
- Assessment of the effect of collagen cross-linking on best-corrected visual acuity
Detailed description
Cross-linking of collagen refers to the ability of collagen fibrils to form strong chemical bonds with adjacent fibrils. In the cornea, collagen cross-linking occurs naturally with aging due to an oxidative deamination reaction that takes place within the end chains of the collagen. It has been hypothesized that this natural cross-linkage of collagen explains why keratectasia (corneal ectasia) often progresses most rapidly in adolescence or early adulthood but tends to stabilize in patients after middle-age.
Human studies of UV-induced corneal cross-linking began in 2003 in Dresden, and early results were promising. The initial pilot study enrolled 16 patients with rapidly progressing keratoconus and all of the patients stopped progressing after treatment. Additionally, 70% had flattening of their steep anterior corneal curvatures (decreases in average and maximum keratometric values), and 65% had an improvement in visual acuity. There were no reported complications.
Per the typical cross-linking protocol, 0.1% riboflavin solution with 20% dextran is added to the de-epithelialized cornea and then photoactivated with UV-A light at 365 nm with irradiance of 3 mW/cm2 for 30 minutes. The cornea is de-epithelialized to allow adequate penetration of riboflavin into the corneal stroma. Riboflavin acts as photosensitizer; it creates free radicals, forms new molecular crosslinks, and ultimately increases the cornea's mechanical strength.
Collagen cross-linking experienced a rapid transition from laboratory procedure to clinical intervention because of the method's apparent safety and broad array of potential applications. One such clinical application is the treatment of keratoconus which is a degenerative disorder of the eye associated with thinning and subsequent bulging of the cornea, causing poor vision. Collagen cross-linking stops the progression of keratoconus in patients with mild disease, presumably by strengthening the cornea and preventing further bulging.
Collagen cross-linking has also been used successfully in the treatment of pellucid marginal degeneration and to treat iatrogenic (postoperative) ectasia. Studies have shown that CXL causes a reduction in corneal edema and thickness with improvement in visual acuity in patients with bullous keratopathy due to different causes. However, these changes last for only about six months and due to this transient effect, CXL may only have a palliative role, if at all, for now.
The effect of cross linking can be assessed postoperatively clinically and also by some devices such as Ocular Response Analyzer (Reichert Inc., Buffalo, NY, USA). The depth of treatment can be measured by the demarcation line, which usually appears at 10 to 14 days after CXL and can be monitored using corneal topography and tomography.
Optical coherence tomography (OCT) is a modality that uses low-coherence interferometry to enable non-contact, in vivo imaging of ocular structures. Since its introduction, OCT imaging has become a key part of clinical evaluation of the cornea, and the anterior eye segment.
As improvements to the technology have increased, e.g. the speed and resolution of the images captured, the impact of anterior segment OCT (AS OCT) imaging on clinical practice, has been rapidly increasing and the clinical potential of the technique in evaluating the cornea had been realized. Specific to the cornea, AS OCT now allows us to image corneal layers and structures in greater detail i.e. epithelium, Bowman's layer, stroma, Descemet membrane and endothelium.
The AS OCT is extremely useful in studying anterior segment pathology through an edematous cornea such as in Descemet membrane detachments , corneal stroma itself and corneal infiltrates secondary to infections.
AS OCT is also useful in assessing changes in cornea postoperative including corneal changes after cross linking. The most widely reported change seen on cross-sectional OCT following CXL has been the appearance of a 'demarcation' line within the corneal stroma. This line has been postulated to represent the depth of the CXL treatment, separating the treated anterior stroma and untreated posterior stroma. The demarcation line is hyper-reflective when viewed with OCT, Scheimpflug imaging and on slit lamp biomicroscopy. OCT provides the ability to measure the depth of the demarcation line and has been used as an important outcome parameter when comparing various CXL protocols. The demarcation line usually fades by three months and, in some corneas, is replaced with faint, irregular, hyper-reflective lines in the deep stroma.
Other changes that can be noted on OCT images following CXL include increased reflectivity of the treated stroma, and the appearance of fainter, secondary stromal demarcation lines.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Age groups
- Adult
- Study population
- patients who underwent classic corneal collagen cross-linking
Key inclusion criteria (1 listed)
- patients with e corneal ectasia who are candidates for CXL.
Key exclusion criteria (3 listed)
- patients with other corneal diseases not treated by collagen cross-linking
- 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 |
|---|---|---|
| anterior segment octAlso: collagen cross linkingant segment oct before and after corneal collagen cross-linking | Device | – |
Primary outcome
corneal thickness after collagen cross linking OCT study
Time frame: 12 months
corneal thickness measurement in mm
1 secondary outcome
corneal demarcation line after collagen cross linking OCT study
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
- Background: PubMed 14522301Wollensak G, Spoerl E, Seiler T. Stress-strain measurements of human and porcine corneas after riboflavin-ultraviolet-A-induced cross-linking. J Cataract Refract Surg. 2003 Sep;29(9):1780-5. doi: 10.1016/s0886-3350(03)00407-3.
- Background: PubMed 23583042Raiskup F, Spoerl E. Corneal crosslinking with riboflavin and ultraviolet A. I. Principles. Ocul Surf. 2013 Apr;11(2):65-74. doi: 10.1016/j.jtos.2013.01.002. Epub 2013 Jan 24.
- Background: PubMed 21724915Brummer G, Littlechild S, McCall S, Zhang Y, Conrad GW. The role of nonenzymatic glycation and carbonyls in collagen cross-linking for the treatment of keratoconus. Invest Ophthalmol Vis Sci. 2011 Aug 11;52(9):6363-9. doi: 10.1167/iovs.11-7585.
- Background: PubMed 27055493Raiskup F, Terai N, Velika V, Sporl E. [Corneal Cross-Linking with Riboflavin and UVA in Keratoconus]. Klin Monbl Augenheilkd. 2016 Aug;233(8):938-44. doi: 10.1055/s-0042-102060. Epub 2016 Apr 7. German.
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.
mohammed saad, professor contact
Questions about this trial
What is this clinical trial studying?
An observational study of Corneal Ectasia of Both Eyes, 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 3 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 19 Jul 2023. 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 Doaa Aly, Master (+2 01061541924, duaazidan75@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
corneal thickness after collagen cross linking OCT study (time frame: 12 months). 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 NCT05717517, which also lists 4 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 19 Jul 2023.