Progressive KeratoconusCACXLNCT04504578
Efficacy and Safety ofCACXL in the Treatment of Keratoconus With Thin Corneas
A study testing contact lens assisted corneal cross linking in people with Progressive Keratoconus, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
The aim of this study is to detect the safety and effectiveness of contact lens assisted corneal cross linking in managing progressive keratoconus with thin corneas CACXL was done for 40 eyes of 30 of keratoconic patients presented to cornea outpatient clinic in Kasr Alainy teaching hospital The UDVA ,BDVA KMAX… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Progressive Keratoconus
- What is being tested?
- contact lens assisted corneal cross linking
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 1 Feb 2019
- Phase
- Interventional
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age from 18 to 35years old Mild , moderate and severe keratoconic patients with a corneal thickness from 360-400 µm at the thinnest location .
Who cannot join
- • Previous corneal surgeries such as rings or crosslinking.
- Patients with stromal corneal scar.
- Other ocular pathology such as glaucoma or iridocyclitis.
- Patient with systemic diseases that likely affects wound healing such as insulin dependent diabetes mellitus.
- Patients with collagen vascular diseases, autoimmune or immune deficiency diseases.
- Pregnant or nursing women.
- Patients taking the following medications ; isotretinoin, amiodarone, sumatriptan.
- Other corneal pathology rather than keratoconus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Contact Lens-assisted Corneal Cross- Linking in the Treatment of Keratoconus With Thin Corneas
The aim of this study is to detect the safety and effectiveness of contact lens assisted corneal cross linking in managing progressive keratoconus with thin corneas CACXL was done for 40 eyes of 30 of keratoconic patients presented to cornea outpatient clinic in Kasr Alainy teaching hospital The UDVA ,BDVA KMAX, thinnest corneal thickness pre-operative and 9 months postoperatively and the endothelial cell count was measured preoperative and 3 months postoperative Demarcation line was measured after 1 month by using ASOCT There was statistical significant difference in UDVA and BDVA, there was stabilization of Kmax there was decrease in endothelial cell count but not statistically significant According to results the procedure seems to be effective and safe un managing progressive keratoconus.
Read the detailed description
Corneal collagen cross linking showed effective results in stabilizing progressive keratoconic corneas. It is the only treatment that halts progression of keratoconus, It was first described in 1998 by Spoerl et al . A major limitation of the procedure that it cannot be used in corneas with pachymetry less than400 micrometers based on the fact that an irradiance of 0.37 mW/cm2 has been found to be cytotoxic for the endothelial cell layer. Since the absorption coefficient for the human corneas is 70 cm-1 and the intended surface irradiance is 3.0 mW/cm2, the 0.37 mW/cm2 irradiance is reached at 300 microns depth. In a 400 microns thick cornea saturated with riboflavin, the irradiance at the endothelial level is 0.18 mW/cm2, which is a factor of 2 smaller than the damage threshold. Therefore, the 400 microns limit is considered to be a safe limit to protect the endothelium and intraocular structures from the hazards of UV irradiation 12 However , the patients with advanced ectasia who are desperately in need for cxl , are the same ones who have thin corneas often below the threshold which is considered to be safe for CXL treatment However further studies with longer follow up and larger numbers of cases are needed to confirm our findings.
- Conditions
- Progressive Keratoconus
- Being tested
- contact lens assisted corneal cross linking
- Keywords
- cross linking, thin corneas, Advanced keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
contact lens assisted corneal cross linkingProcedure or surgery
40 eyes of 30 patients underwent CACXL. The central 9 mm of corneal epithelium was abraded , Iso-tonic riboflavin 0.1% was applied every 2 minutes for 10 minutes on the debrided cornea. A disposable soft Contact lens without an ultraviolet filter (Soflens, Bausch \& Lomb) was placed in the inferior fornix during soaking of the stroma with riboflavin for 10 minutes. The contact lens was applied on the corneal surface and the cornea was exposed to ultraviolet-A irradiation at fluence of 3.0 mW/cm2 for 30 minutes The uncorrected (UDVA) and best corrected (BDVA) visual acuity, and maximum (K max) keratometric values, were assessed before, and after 9 months CXL. Endothelial cell count was assessed before and 3 months after CXL. Anterior segment OCT was done 1 month after CXL to evaluate the presence and depth of the corneal stromal demarcation line.
| Study group | Role | What they receive |
|---|---|---|
| patients with progressive keratoconus with thin corneas | Experimental | patients with progressive keratoconus with thin corneas , with thickness less than 400 micron ,will do conventional cross linking but with putting contact lens over the cornea ( will receive Contact lens assisted corneal cross liking ) Receives: Procedure: contact lens assisted corneal cross linking |
What is being measured
The primary outcome is the main question the study is designed to answer.
kmax
stabilization of the cornea by corneal tomography
Measured: tomography after 9 months
Secondary outcomes (1)
number of endothelial cell count
number of endothelial cell before and after treatment
Measured: 3 months postoperative by specular microscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start1 Jan 2018
- Primary completion1 Jan 2019
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Progressive KeratoconusStudies of the same condition, open and under way.
- 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
- Model description
- patients with progressive keratoconus with thin corneas less than 400 micron
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moustafa Nour, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04504578
- Sponsor's protocol ID
- s5-2019
- Acronym
- CACXL
- Status last verified
- Aug 2020
- First submitted
- 5 Jul 2020
- Last updated
- 7 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nour MM, El-Agha MH, Sherif AM, Shousha SM. Efficacy and Safety of Contact Lens-Assisted Corneal Crosslinking in the Treatment of Keratoconus With Thin Corneas. Eye Contact Lens. 2021 Sep 1;47(9):500-504. doi: 10.1097/ICL.0000000000000799.
PubMed 34001713
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Contact Lens-assisted Corneal Cross- Linking in the Treatment of Keratoconus With Thin Corneas
- ClinicalTrials.gov ID
- NCT04504578
- Acronym / sponsor ID
- CACXL / s5-2019
- Conditions
- Progressive Keratoconus
- Keywords
- cross linking, thin corneas, Advanced keratoconus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 7 Aug 2020 (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 detect the safety and effectiveness of contact lens assisted corneal cross linking in managing progressive keratoconus with thin corneas CACXL was done for 40 eyes of 30 of keratoconic patients presented to cornea outpatient clinic in Kasr Alainy teaching hospital The UDVA ,BDVA KMAX, thinnest corneal thickness pre-operative and 9 months postoperatively and the endothelial cell count was measured preoperative and 3 months postoperative Demarcation line was measured after 1 month by using ASOCT There was statistical significant difference in UDVA and BDVA, there was stabilization of Kmax there was decrease in endothelial cell count but not statistically significant According to results the procedure seems to be effective and safe un managing progressive keratoconus.
Detailed description
Corneal collagen cross linking showed effective results in stabilizing progressive keratoconic corneas. It is the only treatment that halts progression of keratoconus, It was first described in 1998 by Spoerl et al . A major limitation of the procedure that it cannot be used in corneas with pachymetry less than400 micrometers based on the fact that an irradiance of 0.37 mW/cm2 has been found to be cytotoxic for the endothelial cell layer. Since the absorption coefficient for the human corneas is 70 cm-1 and the intended surface irradiance is 3.0 mW/cm2, the 0.37 mW/cm2 irradiance is reached at 300 microns depth. In a 400 microns thick cornea saturated with riboflavin, the irradiance at the endothelial level is 0.18 mW/cm2, which is a factor of 2 smaller than the damage threshold. Therefore, the 400 microns limit is considered to be a safe limit to protect the endothelium and intraocular structures from the hazards of UV irradiation 12 However , the patients with advanced ectasia who are desperately in need for cxl , are the same ones who have thin corneas often below the threshold which is considered to be safe for CXL treatment However further studies with longer follow up and larger numbers of cases are needed to confirm our findings.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- patients with progressive keratoconus with thin corneas less than 400 micron
| Arm | Type | Receives |
|---|---|---|
| patients with progressive keratoconus with thin corneas | Experimental | Procedure: contact lens assisted corneal cross linkingpatients with progressive keratoconus with thin corneas , with thickness less than 400 micron ,will do conventional cross linking but with putting contact lens over the cornea ( will receive Contact lens assisted corneal cross liking ) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age from 18 to 35years old Mild , moderate and severe keratoconic patients with a corneal thickness from 360-400 µm at the thinnest location .
Key exclusion criteria (8 listed)
- • Previous corneal surgeries such as rings or crosslinking.
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 |
|---|---|---|
| contact lens assisted corneal cross linking40 eyes of 30 patients underwent CACXL. The central 9 mm of corneal epithelium was abraded , Iso-tonic riboflavin 0.1% was applied every 2 minutes for 10 minutes on the debrided cornea. A disposable soft Contact lens without an ultraviolet filter (Soflens, Bausch \& Lomb) was placed in the inferior fornix during soaking of the stroma with riboflavin for 10 minutes. The contact lens was applied on the corneal surface and the cornea was exposed to ultraviolet-A irradiation at fluence of 3.0 mW/cm2 for 30 minutes The uncorrected (UDVA) and best corrected (BDVA) visual acuity, and maximum (K max) keratometric values, were assessed before, and after 9 months CXL. Endothelial cell count was assessed before and 3 months after CXL. Anterior segment OCT was done 1 month after CXL to evaluate the presence and depth of the corneal stromal demarcation line. | Procedure or surgery | patients with progressive keratoconus with thin corneas |
Primary outcome
kmax
Time frame: tomography after 9 months
stabilization of the cornea by corneal tomography
1 secondary outcome
number of endothelial cell count
Time frame: 3 months postoperative by specular microscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2020.
- Derived from this study: PubMed 34001713Nour MM, El-Agha MH, Sherif AM, Shousha SM. Efficacy and Safety of Contact Lens-Assisted Corneal Crosslinking in the Treatment of Keratoconus With Thin Corneas. Eye Contact Lens. 2021 Sep 1;47(9):500-504. doi: 10.1097/ICL.0000000000000799.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing contact lens assisted corneal cross linking in people with Progressive Keratoconus, run by Kasr El Aini Hospital at 1 site in Egypt.
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 8 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: finished, as of the sponsor's last update on 7 Aug 2020. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
kmax (time frame: tomography after 9 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 NCT04504578, which also lists 1 linked publication.
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 7 Aug 2020.