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 range

17 Years – 33 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Keratoconus trials