Corneal cross linking in the treatment of juvenile onset early keratoconus

A prospective comparison of corneal cross linking treatment parameters and outcomes for juvenile onset early keratoconus

Status

Terminated

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000601932

Acronym

JXL

Enrollment

102

Registered

2011-06-10

Start date

2011-12-05

Completion date

2011-12-05

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is a proposal to conduct a prospective nonrandomised open trial to assess the effectiveness, safety and efficacy of corneal cross linking in juvenile patients with progressive keratoconus who undergo either low power-long time (LPLT) versus high power-Short time (HPST) corneal cross linking in an attempt to stabilize their keratoconus. Data existing in the patient's notes prior to recruitment will form part of the data collection process.

Interventions

Patients with juvenile onset early keratoconus will be treated with one of two treatment options to assess safety, efficacy of treatment. The 'High power short duration' (6mW/cm2 for 15 minutes) will be considered to be the 'treatment arm'. This is delivered as a single one off event delivered by Optolink(c) Ultraviolet illuminator as part of the process of corneal cross linking for keratoconus.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

5 Years to 17 Years

Healthy volunteers

Inclusion criteria

Early Keratoconus must be evidenced by one or more of the following Pentacam derived topographic abnormalities in the study eye 1. Corneal shape factor indicative of keratoconus on Pentacam assessment Abnormal Enhanced Ectasia Display flags abnormalities based on regression analysis of findings compared to normality indices for (A) Corneal thickness spatial profile (CTSP) (B) Percentage thickness increase (PTI) (C) Deviation parameters (D) 2. Thinnest pachymetry of less than 480microm 3. Kmax of greater than 48 D 4. Posterior corneal elevation of greater than 25 microm on Pentacam analysis and be associated with patient reported history, topographic or refraction data which indicates one of the following changes notes in less than a 12 month period of follow up. 5. Patient reported history of visual loss in study eye during last 1 year. 6. An increase of greater than or equal to 0.75 Diopters (D) in the steepest keratometry value (Kmax on Pentacam). 7. An increase of greater than than or equal to 0.50D in regular astigmatism evaluated by manifest subjective refraction. 8. A myopic shift (decrease in the spherical equivalent) on manifest refraction of 0.50D. 9. Corneal thinning of greater than or equal to 15 microm in less then 12 months on the same pachymeter. 10. Unaided visual acuity in the study eye falling from logmar equivalent recorded level of 1.0 Patients with other keratoconus characteristics will not be entered into the trial but offered follow up on a 3-6 monthly basis and if there unaided vision falls be invited to participate at that point.

Exclusion criteria

Exclusion criteria Eyes will not be eligible to be recruited into the trial if anyone or more of the following apply: 1. Patient age is 18 years or older 2. There is a history of previous corneal surgery. 3. Corneal pachymetry of less than 340microm (thinnest point measured by Pentacam topographer. 4. Insufficient ability to comply with full testing involved in the study 5.The presence of visually significant corneal stromal scarring. 6. The existence of other corneal pathology. 7. A history of herpetic keratitis, chemical injury, or delayed epithelial healing. 8. Recurrent corneal erosion syndrome. 9. Pregnancy or breast-feeding at the time of the initial treatment. 10. Allergy to Riboflavin.

Outcome results