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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00815256
Other study ID # 1970/07
Secondary ID
Status Recruiting
Phase Phase 3
First received December 26, 2008
Last updated December 26, 2008
Start date August 2008

Study information

Verified date November 2008
Source Federal University of São Paulo
Contact Patricia Z Serapicos, MD
Phone 55(11)82738907
Email patricia.serapicos@yahoo.com.br
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 15
Est. completion date
Est. primary completion date August 2009
Accepts healthy volunteers No
Gender Both
Age group 15 Years to 40 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Collagen Cross Linking with Riboflavin and UVA light
The patients randomized and allocated to this group are submitted to the treatment with riboflavin and ultraviolet -A light, if they do not match any of the exclusion criterion. The treatment is done as follows:after topical anesthesia, the epithelial tissue was removed in a 8.0mm diameter area of the central cornea, the 0,1% riboflavin solution were 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 were continuously applied onto the cornea every 5 min. After the procedure, a therapeutic contact lens and antibiotic eye ointment are applied onto the cornea for a week. We see the patient in the next day.

Locations

Country Name City State
Brazil Department of Ophthalmology, Federal University of São Paulo São Paulo SP

Sponsors (1)

Lead Sponsor Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

Raiskup-Wolf F, Hoyer A, Spoerl E, Pillunat LE. Collagen crosslinking with riboflavin and ultraviolet-A light in keratoconus: long-term results. J Cataract Refract Surg. 2008 May;34(5):796-801. doi: 10.1016/j.jcrs.2007.12.039. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Stop progression of keratoconus in cornea imaging exams 1, 3, 6 and 12 months Yes
Secondary Increase in the collagen fibrils density in the confocal microscopy; sensitivity in the esthesiometry; Keratometry (stabilizes or reduces) in the topography; anterior chamber depth on pentacan; etc 1, 3, 6 and 12 months Yes
See also
  Status Clinical Trial Phase
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Completed NCT02883868 - Stromal Demarcation Line: is it Predictive for Cross-Linking Efficiency? N/A
Active, not recruiting NCT04427956 - Corneal Crosslinking Treatment Study Phase 4
Terminated NCT01868620 - Non-inferiority Trial of Iontophoretic Corneal Collagen Crosslinking (CXL) Compared to Standard Corneal Collagen Crosslinking in Progressive Keratoconus. N/A
Recruiting NCT05314738 - Safety and Efficacy of Corneal Cross-linking in Subjects With Keratoconus Phase 1/Phase 2
Not yet recruiting NCT06450470 - Use of a Freeze-dried Amniotic Membrane Post Crosslinking in Subjects With Progressive Keratoconus Phase 3
Completed NCT02117999 - Transepithelial Corneal Cross-linking Using Iontophoresis N/A
Completed NCT01485211 - Corneal Thickness Changes During Corneal Collagen Cross-linking With Ultraviolet-A Irradiation and Riboflavin Phase 4
Completed NCT04504578 - Efficacy and Safety ofCACXL in the Treatment of Keratoconus With Thin Corneas N/A
Completed NCT00647699 - Corneal Collagen Cross-linking for Progressive Keratoconus Phase 3
Completed NCT00567671 - Corneal Collagen Cross-Linking for the Treatment of Progressive Keratoconus and Corneal Ectasia Phase 2/Phase 3
Recruiting NCT04045626 - Study of Demarcation Line Depth in Transepithelial Versus Epithelium-off Accelerated Cross-linking (AXL) in Keratocouns N/A
Completed NCT03442751 - Study to Evaluate the Safety and Efficacy of Epi-on Corneal Cross-linking in Eyes With Progressive Keratoconus Phase 3
Withdrawn NCT00679666 - Corneal Crosslinking in Keratoconus and Corneal Ectasia Phase 2/Phase 3
Completed NCT01411384 - Evaluation of Corneal Hysteresis and Corneal Resistance Factor After Corneal Cross-linking for Keratoconus N/A
Not yet recruiting NCT00925327 - Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking for Compassionate Treatment in Pediatric Patients With Progressive Keratoconus Phase 2