NCT02008175

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 2, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 11, 2013

Completed
Last Updated

December 16, 2013

Status Verified

December 1, 2013

Enrollment Period

1.4 years

First QC Date

December 2, 2013

Last Update Submit

December 12, 2013

Conditions

Keratoconus

Keywords

paediatric, keratoconus, collagen cross linking

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Improvement in vision

    12 months

Study Arms (1)

Conventional CXL

EXPERIMENTAL

Crosslinking was done according to the standard protocol using hypo-osmolar riboflavin to saturate the cornea following epithelial debridement and ultra - violet light of 370nm with energy density of 3 milliwatts/sq.cm with riboflavin and distilled water alternated every 2 minutes was used for the procedure.

Radiation: Conventional CXL

Interventions

Conventional CXLRADIATION

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..

Also known as: Conventional collagen cross linking, C3R, Dresden protocol.
Conventional CXL

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients aged 18 years and below.
  • Patients diagnosed to have keratoconus at presentation and willing for follow - up at regular intervals post treatment.

You may not qualify if:

  • Any disease causing abnormal topography other than keratoconus.
  • Any ocular condition predisposing towards poor vision (retinal , lens problems)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vasan Eye Care Hospital

Chennai, Tamil Nadu, 600015, India

Location

Related Publications (3)

  • 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.

    PMID: 22633357BACKGROUND

  • 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.

    PMID: 23347367BACKGROUND

  • 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.

    PMID: 22420024BACKGROUND

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Study Officials

  • Dr.Anand Parthasarathy

    Vasan Eye Care Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Anand Parthasarathy

Study Record Dates

First Submitted

December 2, 2013

First Posted

December 11, 2013

Study Start

January 1, 2012

Primary Completion

June 1, 2013

Study Completion

November 1, 2013

Last Updated

December 16, 2013

Record last verified: 2013-12

Locations

IN(1)