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

Completed

• Conditions: Keratoconus
• Interventions: Procedure: Epithelium-on corneal cross-linking (epi-on CXL)

• Registration Number: NCT06267495
• Lead Sponsor: Assiut University

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.

Detailed Description

Keratoconus (KC) is a bilateral asymmetric progressive corneal degenerative disease associated with corneal thinning and protrusion with resultant irregular astigmatism and visual loss.

Although several studies showed that epithelium-off corneal cross-linking (epi-off CXL) is more effective in preventing KC progression compared with epithelium-on corneal cross-linking (epi-on CXL), the removal of corneal epithelium in epi-off CXL might be associated with a number of serious complications such as persistent epithelial defects and sight-threatening infectious keratitis. Additionally, recent systematic reviews and meta-analysis concluded that epi-on CXL is as effective as epi-off CXL in terms of visual and topographic stability of keratoconus, but has the advantage of being much safer avoiding the complications of epithelial removal.

The management of the better eye, of young patients with unilateral clinically evident KC, is controversial. Some ophthalmologists prefer to cross-link the better eye, while others prefer to conservatively follow it up, in order to avoid complications of epithelial removal in epi-off CXL.

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2024-01-31
• Study Completion: 2024-01-31
• Status Verified: 2024-02
• Study First Submitted: 2024-02-12
• Study First Submitted QC: 2024-02-19
• Last Update Submitted: 2024-02-19
• Study First Posted: 2024-02-20
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Patients aged 12 to 30 years presented with forme fruste (FFKC) or subclinical KC, based on the following criteria:

1. Normal slit lamp examination
2. 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)
3. Clinical and topographic features of KC in the other eye.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Maximum keratometry value	24 months	The maximum keratometry is measured using pentacam. A higher value means a worse outcome.
Steep keratometry value	24 months	The steep keratometry is measured using pentacam. A higher value means a worse outcome.

Secondary Outcome Measures

Name	Time	Method
Corrected distance visual acuity	24 months	Corrected distance visual acuity (CDVA) is measured with Snellen's acuity chart and converted to logarithm of the minimum angle of resolution (logMAR) notation.; The higher the logMAR CDVA, the worse the outcome.

Trial Locations

Locations (1)

Tiba Eye Center; 🇪🇬 Assiut, Egypt