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

Cairo University39 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Keratoconus

Interventions

Corneal collagen cross-linking with induction of corneal stromal emphysemaPROCEDURE

Corneal collagen cross-linking with induction of corneal stromal emphysema

Eligibility

Sex: ALLMin age: 17 YearsMax age: 33 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Ophthalmology-Faculty of Medicine-Cairo University

Giza, Giza Governorate, Egypt

Outcomes

Primary Outcomes

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

Through serial corneal tomography

Time frame: 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

Time frame: 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

Time frame: one month after procedure

Secondary Outcomes

To detect changes in the visual acuity (in decimal)

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

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

Data from ClinicalTrials.gov

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