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NCT04504578: CACXL

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

Completed NA Last updated 7 August 2020
What this trial tests

NA trial testing contact lens assisted corneal cross linking in Progressive Keratoconus in 30 participants. Completed in 1 February 2019.

Timeline
1 January 2018
Primary endpoint
1 January 2019
1 February 2019

Quick facts

Lead sponsorKasr El Aini Hospital
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment30
Start date1 January 2018
Primary completion1 January 2019
Estimated completion1 February 2019
Sites1 location across Egypt

Drugs / interventions tested

Conditions studied

Sponsor

Kasr El Aini Hospital

Who can join

Adults 18 to 40, any sex, with Progressive Keratoconus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Efficacy and Safety of Contact Lens-Assisted Corneal Crosslinking in the Treatment of Keratoconus With Thin Corneas.
    Nour MM, El-Agha MH, Sherif AM, Shousha SM. · · 2021 · cited 9× · PMID 34001713 · DOI 10.1097/icl.0000000000000799

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