Safety and Effectiveness of Collagen Cross Linking in Progressive Mild and Moderate Keratoconus

Federal University of São Paulo

Status and phase: Unknown; Phase 3

Conditions: Progressive Keratoconus; Cornea Degeneration

Treatments: Procedure: Collagen Cross Linking with Riboflavin and UVA light

Study type: Interventional

Funder types: Other

Identifiers

NCT00815256

1970/07

Details and patient eligibility

About

The purpose of this study is to evaluate the effectiveness of collagen cross linking (CXL) in reducing progression of mild and moderate progressive keratoconus.

Full description

Keratoconus is a corneal degeneration characterized by bilateral conical protusion and corneal thinning. The course of the disease varies from slight irregular astigmatism to severe visual impairment due to increasing protrusion and subepithelial scarring. There is no treatment available that can stop keratoconus progression. Thus, because of its progressive nature, keratoconus is the most frequent reason for keratoplasty worldwide in the past 3 decades.

The collagen crosslinking (CXL) technique using riboflavin and ultraviolet - A (UVA) light was recently developed to counteract the progressive corneal thinning, and thus the progression of keratoconus. With crosslinking, additional covalent binding between collagen molecules can be achieved, which stabilizes the collagen scaffold and enhances corneal resistance.

Prospective longitudinal randomized case-control study including progressive keratoconus cases is addressed to evaluate the effectiveness of collagen cross linking (CXL) in reducing progression of mild and moderate progressive keratoconus. Progression is based on increase in the cone apex keratometry of - 0,75 D, alteration of - 0,75 D in the spherical equivalent or increase of the anterior chamber depth on Pentacan, in a period of at least six months. All patients must be between 15 and 40 year old and are randomized and allocated in the treated or the control groups. Complete exam before and after exam included best corrected visual acuity, refraction, IOP, fundoscopy, imaging exams such as corneal computerized topographic, pentacan, orbscan, ultrasound pachymetry, esthesiometry, endothelial cell count, HRT II system confocal microscopy, optic coherence tomography (VISANTE), ORA , optic coherence tomography (Stratus OCT) and dynamic contour tonometry . All the exams are repeated 1, 3, 6 and 12 months after the procedure. The cross linking is performed as follows: after topical anesthesia, the epithelial tissue is removed in a 8.0mm diameter area of the central cornea, the 0,1% riboflavin solution is applied every 2 min, for 30 min followed by cornea irradiation with UVA light with a wavelength of 370 nm and an irradiance of 3 mW/cm2. During the irradiation, drops of the riboflavin solution is continuously applied onto the cornea every 5 min.

Enrollment: 15 estimated patients

Sex: All

Ages: 15 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Keratoconus patients, with progression of the disease, based on an increase in the cone apex keratometry of - 0,75 D, alteration of - 0,75 D in the spherical equivalent or increase of the anterior chamber depth on pentacan, in a period of at least six months.

Exclusion criteria

• pregnancy, corneal thickness less than 400 μm, history of corneal surgery, herpes ocular infection, other corneal disease or scarring, chemical injuries and riboflavin allergy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

15 participants in 1 patient group

Cross linking (CXL)

Experimental group

Description:

Patients with progressive mild and moderate grades of ketatoconus are randomized and allocated to this group and submitted to the treatment with riboflavin and ultraviolet -A light. They do not match any of the exclusion criterion: pregnancy, corneal thickness less than 400 μm, history of corneal surgery, herpes ocular infection, other corneal disease or scarring, chemical injuries and riboflavin allergy.

Treatment:

Procedure: Collagen Cross Linking with Riboflavin and UVA light