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Study of Demarcation Line Depth in Transepithelial Versus Epithelium-off Accelerated Cross-linking (AXL) in Keratocouns

K

Kasr El Aini Hospital

Status

Unknown

Conditions

Progressive Keratoconus

Treatments

Procedure: corneal cross-linking

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

To assess depth of demarcation line in transepithelial versus epithelium-off accelerated cross-linking in keratoconus patients

Full description

Anterior segment optical coherence tomography "OCT" will be performed to evaluate the corneal stroma for the presence of demarcation line 1 month postoperatively by an independent observer unware of purpose of study

Enrollment

20 estimated patients

Sex

All

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • progressive keratoconus stage 1-2

Exclusion criteria

  • any concomitant ocular disease

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

20 participants in 2 patient groups

Transepithelial accelerated cross-linking
Active Comparator group
Description:
Paracel is instilled 1 drop every 1.5 minutes for 4.5 minutes then vibex-xtra is instilled 4 drops at 5.5 minutes followed by 1 drop at 6.5 minutes for a total soak time of 11 minutes followed by ultraviolet-A" UVA" irradiation with intended irradiance of 45mW/cm2 for 2.4 minutes
Treatment:
Procedure: corneal cross-linking
Epithelium-off accelerated cross-linking
Active Comparator group
Description:
Vibex-rapid is instilled every 2 minutes for 10 minutes followed by ultraviolet-A "UVA" irradiation of 30 mW/cm2 for 4 minutes
Treatment:
Procedure: corneal cross-linking

Trial contacts and locations

1

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Central trial contact

Sarah Azzam, MD

Data sourced from clinicaltrials.gov

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