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

NCT04504578 | Completed

• 1 other identifier: s5-2019
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Progressive Keratoconus

Keywords

cross linking; thin corneas; Advanced keratoconus

Outcome Measures

Primary Outcomes (1)

• kmax

  stabilization of the cornea by corneal tomography

  tomography after 9 months

Secondary Outcomes (1)

• number of endothelial cell count

  3 months postoperative by specular microscopy

Study Arms (1)

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 )

Procedure: contact lens assisted corneal cross linking

Interventions

contact lens assisted corneal cross linking PROCEDURE

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.

patients with progressive keratoconus with thin corneas

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasrelaini Hospital

Cairo, 12654, Egypt

Location

Related Publications (1)

• 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.

  PMID: 34001713 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Model Details: patients with progressive keratoconus with thin corneas less than 400 micron

Study Record Dates

• First Submitted: July 5, 2020
• First Posted: August 7, 2020
• Study Start: January 1, 2018
• Primary Completion: January 1, 2019
• Study Completion: February 1, 2019
• Last Updated: August 7, 2020

Record last verified: 2020-08

Locations

EG (1)