Clinical trial NCT06267495: Epithelium-on Cross-linking Versus Observation of Fellow Eyes of Patients With Unilateral Clinically Evident Keratoconus
Official title: Epithelium-on Accelerated Corneal Cross-linking Versus Observation of Fellow Eyes of Young Patients With Unilateral Clinically Evident Keratoconus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Keratoconus
Keywords: Keratoconus
Corneal cross-linking
Epithelium-on CXL
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Steep keratometry value
timeFrame: 24 months
measure: Maximum keratometry value
timeFrame: 24 months
Secondary outcomes:
measure: Corrected distance visual acuity
timeFrame: 24 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Tiba Eye Center
Study officials:
affiliation: Assiut University
name: Mahmoud Abdel-Radi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.