Conventional Collagen Crosslinking in Young Keratoconus

Not Applicable

Completed

• Conditions: Keratoconus
• Interventions: Radiation: Conventional CXL

• Registration Number: NCT02008175
• Lead Sponsor: Vasan Eye Care Hospital

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.

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2013-06
• Study Completion: 2013-11
• Status Verified: 2013-12
• Study First Submitted: 2013-12-02
• Study First Submitted QC: 2013-12-05
• Study First Posted: 2013-12-11
• Last Update Submitted: 2013-12-12
• Last Update Posted: 2013-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Conventional CXL	Conventional CXL	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.

Primary Outcome Measures

Name	Time	Method
Change in Keratometric indices	1 months	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

Name	Time	Method
Improvement in vision	12 months	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.

Trial Locations

Locations (1)

Vasan Eye Care Hospital; 🇮🇳 Chennai, Tamil Nadu, India