CompletedNot Applicable

Effectiveness and Safety of Corneal Collagen Cross Linking After Induction of Stromal Emphysema in Keratoconus

Egypt39 participantsStarted 2022-10-01

Plain-language summary

in this study we evaluated the effectiveness and safety of corneal collagen cross-linking in keratoconic eyes with thin cornea after induction of stromal emphysema prior to riboflavin instillation and UV-A corneal irradiation

Who can participate

Age range17 Years – 33 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Progressive KC proven by clinical examination, tomography, and pachymetry * Thinnest corneal location thickness between 390 to 450 microns Exclusion Criteria: * Previous ocular Trauma or Surgery. * History of herpetic eye disease * Central corneal scarring * Cornea guttata * Ocular surface disease and dry eye disease * Vernal and atopic keratoconjunctivitis * Cataract * Glaucoma, intraocular pressure less than 10 or more than 21 mmHg * Posterior segment abnormalities * Nystagmus or other conditions that interfere with patient's fixation * Diabetes mellitus * pregnancy * Collagen vascular disease, autoimmune disease and patients receiving immunosuppressive therapy

What they're measuring

Evaluating effectiveness of Cross-linking in the presence of air in corneal stroma

Timeframe: Corneal tomography will be performed preoperatively then 6, and 12 months after the procedure

Assessment of the safety of this procedure on corneal endothelial cells

Timeframe: Specular microscopy will be performed preoperatively, then 1, 3 and 6 months after the procedure

Measuring demarcation line depth in microns from corneal epithelium

Timeframe: one month after procedure

Trial details

NCT IDNCT07426029

SponsorCairo University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-01

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