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

NCT07426029 | Completed DMC

• 1 other identifier: MD-163-2023
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Keratoconus

Outcome Measures

Primary Outcomes (3)

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

  Through serial corneal tomography

  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

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

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

• Measuring demarcation line depth in microns from corneal epithelium

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

  one month after procedure

Secondary Outcomes (1)

• To detect changes in the visual acuity (in decimal)

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

Study Arms (1)

Patients with progressive keratoconus

OTHER

Procedure: Corneal collagen cross-linking with induction of corneal stromal emphysema

Interventions

Corneal collagen cross-linking with induction of corneal stromal emphysema PROCEDURE

Corneal collagen cross-linking with induction of corneal stromal emphysema

Patients with progressive keratoconus

Eligibility Criteria

• Age: 17 Years - 33 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Progressive KC proven by clinical examination, tomography, and pachymetry
• Thinnest corneal location thickness between 390 to 450 microns

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Department of Ophthalmology-Faculty of Medicine-Cairo University

Giza, Giza Governorate, 11562, Egypt

Location

MeSH Terms

Conditions

Keratoconus

Interventions

Corneal Cross-Linking

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Photochemotherapy; Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Ophthalmology, Principal investigator

Model Details: prospective, interventional, case series

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: February 23, 2026
• Study Start: October 1, 2022
• Primary Completion: July 1, 2024
• Study Completion: October 1, 2024
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)