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Conventional Collagen Crosslinking in Young Keratoconus (PED-CXL)

Primary Purpose

Keratoconus

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Conventional CXL
Sponsored by
Vasan Eye Care Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconus focused on measuring paediatric, keratoconus, collagen cross linking

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Vasan Eye Care Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Conventional CXL

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 2, 2013
Last Updated
December 12, 2013
Sponsor
Vasan Eye Care Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02008175
Brief Title
Conventional Collagen Crosslinking in Young Keratoconus
Acronym
PED-CXL
Official Title
Evaluation of Conventional Collagen Crosslinking in Young Keratoconus.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vasan Eye Care Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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; Rapid rates of progression in young keratoconic corneas as compared to adults. Poor biomechanical properties of young corneas. Poor quality of vision, which predisposes to a very poor quality of life. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus
Keywords
paediatric, keratoconus, collagen cross linking

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional CXL
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Conventional CXL
Other Intervention Name(s)
Conventional collagen cross linking, C3R, Dresden protocol.
Intervention Description
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..
Primary Outcome Measure Information:
Title
Change in Keratometric indices
Description
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.
Time Frame
1 months
Secondary Outcome Measure Information:
Title
Improvement in vision
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr.Anand Parthasarathy
Organizational Affiliation
Vasan Eye Care Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vasan Eye Care Hospital
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600015
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
22633357
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.
Results Reference
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PubMed Identifier
23347367
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.
Results Reference
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PubMed Identifier
22420024
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.
Results Reference
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Conventional Collagen Crosslinking in Young Keratoconus

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