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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07426029

Enrollment

Registered

2026-02-23

Start date

2022-10-01

Completion date

2024-10-01

Last updated

2026-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keratoconus

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

Interventions

PROCEDURECorneal collagen cross-linking with induction of corneal stromal emphysema

Corneal collagen cross-linking with induction of corneal stromal emphysema

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

prospective, interventional, case series

Eligibility

Sex/Gender

ALL

Age

17 Years to 33 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Evaluating effectiveness of Cross-linking in the presence of air in corneal stroma	Corneal tomography will be performed preoperatively then 6, and 12 months after the procedure	Through serial corneal tomography
Assessment of the safety of this procedure on corneal endothelial cells	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
Measuring demarcation line depth in microns from corneal epithelium	one month after procedure	both reflectivity and depth (in microns) of demarcation line will be evaluated by using corneal OCT

Secondary

Measure	Time frame	Description
To detect changes in the visual acuity (in decimal)	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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026