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OpenTrials
Completed

NCT Number: NCT02008175

Conventional Collagen Crosslinking in Young Keratoconus

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.

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Key information

Conditions

Keratoconus Corneal Diseases Eye Diseases

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vasan Eye Care Hospital

Chennai, Tamil Nadu, 600015, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Conventional CXL

Radiation

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..

Other names: Conventional collagen cross linking, C3R, Dresden protocol.

Primary outcomes

  1. Change in Keratometric indices

    Time frame: 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 outcomes

  1. Improvement in vision

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Vasan Eye Care Hospital

Other

Registry information

Official study title

Evaluation of Conventional Collagen Crosslinking in Young Keratoconus.

Acronym: PED-CXL

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 11, 2013
Registry last updated
Dec 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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