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Completed

NCT Number: NCT07426029

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

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

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Key information

Conditions

Keratoconus Corneal Diseases Eye Diseases

Age range

17 year–33 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Ophthalmology-Faculty of Medicine-Cairo University

Giza, Giza Governorate, 11562, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Corneal collagen cross-linking with induction of corneal stromal emphysema

Procedure

Corneal collagen cross-linking with induction of corneal stromal emphysema

Primary outcomes

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

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

    Through serial corneal tomography

  2. Assessment of the safety of this procedure on corneal endothelial cells

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

    By evaluating corneal endothelium structural integrity, using serial specular microscopy imaging

  3. Measuring demarcation line depth in microns from corneal epithelium

    Time frame: one month after procedure

    both reflectivity and depth (in microns) of demarcation line will be evaluated by using corneal OCT

Secondary outcomes

  1. To detect changes in the visual acuity (in decimal)

    Time frame: preoperatively then 1 week and 1, 3, 6, and 12 months after the procedure.

    Preoperative and postoperative examinations will be carried out for visual acuity, using Snellen visual acuity chart.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 23, 2026
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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