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

Keratoconus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06267495
• Other study ID #: EOCXLFE
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: January 31, 2024

Study information

• Verified date: February 2024
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Keratoconus

Intervention

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

Locations

Country	Name	City	State
Egypt	Tiba Eye Center	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Steep keratometry value	The steep keratometry is measured using pentacam. A higher value means a worse outcome.	24 months
Primary	Maximum keratometry value	The maximum keratometry is measured using pentacam. A higher value means a worse outcome.	24 months
Secondary	Corrected distance visual acuity	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.	24 months