search
Back to results

Efficacy and Safety ofCACXL in the Treatment of Keratoconus With Thin Corneas (CACXL)

Primary Purpose

Progressive Keratoconus

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
contact lens assisted corneal cross linking
Sponsored by
Kasr El Aini Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Progressive Keratoconus focused on measuring cross linking, thin corneas, Advanced keratoconus

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age from 18 to 35years old Mild , moderate and severe keratoconic patients with a corneal thickness from 360-400 µm at the thinnest location .

Exclusion Criteria:

  • • 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

Sites / Locations

  • Kasrelaini Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

patients with progressive keratoconus with thin corneas

Arm Description

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 )

Outcomes

Primary Outcome Measures

kmax
stabilization of the cornea by corneal tomography

Secondary Outcome Measures

number of endothelial cell count
number of endothelial cell before and after treatment

Full Information

First Posted
July 5, 2020
Last Updated
August 6, 2020
Sponsor
Kasr El Aini Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04504578
Brief Title
Efficacy and Safety ofCACXL in the Treatment of Keratoconus With Thin Corneas
Acronym
CACXL
Official Title
Efficacy and Safety of Contact Lens-assisted Corneal Cross- Linking in the Treatment of Keratoconus With Thin Corneas
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
January 1, 2019 (Actual)
Study Completion Date
February 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Progressive Keratoconus
Keywords
cross linking, thin corneas, Advanced keratoconus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
patients with progressive keratoconus with thin corneas less than 400 micron
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patients with progressive keratoconus with thin corneas
Arm Type
Experimental
Arm Description
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 )
Intervention Type
Procedure
Intervention Name(s)
contact lens assisted corneal cross linking
Intervention Description
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.
Primary Outcome Measure Information:
Title
kmax
Description
stabilization of the cornea by corneal tomography
Time Frame
tomography after 9 months
Secondary Outcome Measure Information:
Title
number of endothelial cell count
Description
number of endothelial cell before and after treatment
Time Frame
3 months postoperative by specular microscopy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age from 18 to 35years old Mild , moderate and severe keratoconic patients with a corneal thickness from 360-400 µm at the thinnest location . Exclusion Criteria: • 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
Facility Information:
Facility Name
Kasrelaini Hospital
City
Cairo
ZIP/Postal Code
12654
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
34001713
Citation
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.
Results Reference
derived

Learn more about this trial

Efficacy and Safety ofCACXL in the Treatment of Keratoconus With Thin Corneas

We'll reach out to this number within 24 hrs