Conventional Collagen Crosslinking in Young Keratoconus

Keratoconus Clinical Trial

— PED-CXL  

Official title:

Evaluation of Conventional Collagen Crosslinking in Young Keratoconus.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02008175
• Other study ID #: PED_CXL
• Status: Completed
• Phase: N/A
• First received: December 2, 2013
• Last updated: December 12, 2013
• Start date: January 2012
• Est. completion date: November 2013

Study information

• Verified date: December 2013
• Source: Vasan Eye Care Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Keratoconus is a chronic progressive non - inflammatory disorder characterised by progressive steepening and thinning of cornea and high myopic astigmatism, accounting for poor visual acuity in such individuals. Keratoconus seems to be more advanced on presentation, in young patients.

The investigators intend to evaluate the effectiveness of conventional collagen cross linking in young patients diagnosed with keratoconus.

Description:

Keratoconus is progressive ectatic corneal disorder characterised by progressive corneal thinning, steep corneal curvatures and usually associated with high irregular myopic astigmatism.

The major problems concerning keratoconus in young patients are;

1. Rapid rates of progression in young keratoconic corneas as compared to adults.

2. Poor biomechanical properties of young corneas.

3. Poor quality of vision, which predisposes to a very poor quality of life.

4. High rates of complications and failure post keratoplasty in young patients.

The investigators intend to evaluate the effectiveness of conventional collagen crosslinking in young patients with keratoconus with regards to keratometric indices and visual acuity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: November 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 18 Years

Eligibility

Inclusion Criteria:

• Patients aged 18 years and below.

• Patients diagnosed to have keratoconus at presentation and willing for follow - up at regular intervals post treatment.

Exclusion Criteria:

• Any disease causing abnormal topography other than keratoconus.

• Any ocular condition predisposing towards poor vision (retinal , lens problems)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Keratoconus

Intervention

Radiation:
• Conventional CXL
Crosslinking was done according to the standard protocol using hypo-osmolar riboflavin (<0.1%) to saturate the cornea following epithelial debridement and ultra - violet light of 370nm with energy density of 3 milliwatts/cm2 with riboflavin and distilled water alternated every 2 minutes was used for the procedure..

Locations

Country	Name	City	State
India	Vasan Eye Care Hospital	Chennai	Tamil Nadu

Sponsors (1)

Lead Sponsor	Collaborator
Vasan Eye Care Hospital

Country where clinical trial is conducted

India, 

References & Publications (3)

Caporossi A, Mazzotta C, Baiocchi S, Caporossi T, Denaro R, Balestrazzi A. Riboflavin-UVA-induced corneal collagen cross-linking in pediatric patients. Cornea. 2012 Mar;31(3):227-31. — View Citation

Chatzis N, Hafezi F. Progression of keratoconus and efficacy of pediatric [corrected] corneal collagen cross-linking in children and adolescents. J Refract Surg. 2012 Nov;28(11):753-8. doi: 10.3928/1081597X-20121011-01. Erratum in: J Refract Surg. 2013 Jan;29(1):72. — View Citation

Vinciguerra P, Albé E, Frueh BE, Trazza S, Epstein D. Two-year corneal cross-linking results in patients younger than 18 years with documented progressive keratoconus. Am J Ophthalmol. 2012 Sep;154(3):520-6. doi: 10.1016/j.ajo.2012.03.020. Epub 2012 May 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Keratometric indices	The keratometric readings in the steepest and flattest meridians, along with the average K readings were compared pre and post treatment using conventional collagen cross linking technique at 1 month post cross linking.	1 months	No
Secondary	Improvement in vision	Comparison of visual rehabilitation was done as improvements noted in Snellen line numbers and best corrected visual acuity (B.C.V.A) converted to decimals, pre and post treatment at 1,3,6,12 months post treatment.	12 months	No