Clinical trial NCT02008175: Conventional Collagen Crosslinking in Young Keratoconus
Official title: Evaluation of Conventional Collagen Crosslinking in Young Keratoconus.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Keratoconus
Keywords: paediatric, keratoconus, collagen cross linking
Lead sponsor: Vasan Eye Care Hospital
Sponsor class: OTHER
First posted: 2013-12-11
Enrollment: 21
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in Keratometric indices
timeFrame: 1 months
Secondary outcomes:
measure: Improvement in vision
timeFrame: 12 months
Other outcomes:
Locations:
city: Chennai
country: India
facility: Vasan Eye Care Hospital
state: Tamil Nadu
Study officials:
affiliation: Vasan Eye Care Hospital
name: Dr.Anand Parthasarathy
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vinciguerra P, Albe 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.
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.
citation: 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. doi: 10.1097/ico.0b013e31822159f6.