Epithelium-on Cross-linking Versus Observation of Fellow Eyes of Patients With Unilateral Clinically Evident Keratoconus

NCT06267495 | Completed

• 1 other identifier: EOCXLFE
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Keratoconus (KC) is a bilateral asymmetric progressive corneal degenerative disease. The management of young patients, diagnosed with clinically evident KC in one eye and with no clinical signs of KC in the other eye, represents a real challenge for many ophthalmologists. The aim of the current study is to investigate the effectiveness and safety of epithelium-on accelerated CXL to stabilize the eye with no clinical signs of KC, in young patients with unilateral clinically evident KC, compared with standard care and follow-up only.

Conditions

Keratoconus

Keywords

Keratoconus; Corneal cross-linking; Epithelium-on CXL

Outcome Measures

Primary Outcomes (2)

• Steep keratometry value

  The steep keratometry is measured using pentacam. A higher value means a worse outcome.

  24 months

• Maximum keratometry value

  The maximum keratometry is measured using pentacam. A higher value means a worse outcome.

  24 months

Secondary Outcomes (1)

• Corrected distance visual acuity

  24 months

Study Arms (2)

Epithelium-on corneal cross-linking group

Patients in this group underwent epithelium-on accelerated corneal cross-linking (epi-on CXL) for the eye with no clinical signs of keratoconus.

Procedure: Epithelium-on corneal cross-linking (epi-on CXL)

Follow-up group

Patients in this group were planned to have regular follow-up visits, without intervention, for the eye with no clinical signs of keratoconus.

Interventions

Epithelium-on corneal cross-linking (epi-on CXL) PROCEDURE

In epithelium-on corneal cross-linking (epi-on CXL), the cornea is soaked with riboflavin for 10 minutes (Paracel® for 4 minutes and VibeX-xtra® for 6 minutes) . Thereafter, the cornea is subjected to ultraviolet A at a wavelength of 370 nm to give a total dose of 5.4 J/cm² through 10 milliwatt mW/cm² for 9 minutes.

Epithelium-on corneal cross-linking group

Eligibility Criteria

• Age: 12 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

This retrospective comparative study was conducted at a refractive and corneal surgery center in Assiut (Private practice). The study included young patients who were diagnosed with forme fruste or subclinical keratoconus.

You may qualify if:

• Patients aged 12 to 30 years presented with forme fruste (FFKC) or subclinical KC, based on the following criteria:
• Normal slit lamp examination
• Normal topography in FFKC and suspicious topography in subclinical KC with asymmetric bow-tie or inferior steeping (inferior-superior value less than 1.40 D in the anterior sagittal curvature map in pentacam)
• Clinical and topographic features of KC in the other eye.

You may not qualify if:

• Corrected distance visual acuity (CDVA) worse than 0.1 logMAR
• Corneal thickness at the thinnest location less than 400 μm
• Severe ocular allergy (active catarrhal keratoconjunctivitis)
• Other corneal or ocular diseases
• Systemic diseases such as diabetes mellitus and autoimmune diseases

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Tiba Eye Center

Asyut, 71516, Egypt

Location

Related Publications (2)

• Koh S, Inoue R, Maeda N, Kabata D, Shintani A, Jhanji V, Klyce SD, Maruyama K, Nishida K. Long-term Chronological Changes in Very Asymmetric Keratoconus. Cornea. 2019 May;38(5):605-611. doi: 10.1097/ICO.0000000000001890.

  PMID: 30702472 BACKGROUND

• Henriquez MA, Hadid M, Izquierdo L Jr. A Systematic Review of Subclinical Keratoconus and Forme Fruste Keratoconus. J Refract Surg. 2020 Apr 1;36(4):270-279. doi: 10.3928/1081597X-20200212-03.

  PMID: 32267959 BACKGROUND

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 Officials

• Mahmoud Abdel-Radi, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: February 20, 2024
• Study Start: January 1, 2017
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)