Conventional Collagen Crosslinking in Young Keratoconus

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Conventional Collagen Crosslinking in Young Keratoconus.

Conditions
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Keratoconus

Intervention / Treatment
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* Radiation: Conventional CXL


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conventional CXL<br>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<br>* 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..<br>* Other names: Conventional collagen cross linking, C3R, Dresden protocol.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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paediatric, keratoconus, collagen cross linking