Cerebral visual impairment Nervous System Diseases
Conditions
Interventions
Eligible children with consenting parents will be screened for severe refractive error prior to randomisation by the research optometrist. Evidence of severe refractive error will result in a referral
Sponsors
Great Ormond Street Hospital for Children NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Term infants undergoing therapeutic hypothermia for hypoxic ischaemic encephalopathy (HIE) 2. Preterm infants born at <29 weeks’ gestational age 3. No gender criteria 4. Age range: new-born to <8 weeks CGA
Exclusion criteria
Exclusion criteria: 1. Infants who are still an inpatient at 8 weeks CGA 2. Ocular exclusion criteria: children with unrelated congenital or developmental ocular abnormality such as cataract requiring surgery, genetic retinal disease, coloboma. Retinopathy of prematurity will not be an exclusion criterion 3. Infants with severe refractive error (more than -6.00D spherical equivalent or +8.00D spherical equivalent)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility is assessed using the acceptance of randomisation over the 10-month recruitment period – this will be measured as the proportion of patients/parents who accept the offer of randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Success rate of compliance with glasses for infants in groups B1 and B2. The proportion of infants (%) who are still wearing their glasses at the 3 and 6 month follow-up appointments. Time frame: 6 months 2. Success rate in dispensing glasses to children in groups B1 and B2. The percentage of infants dispensed vs. the total number of infants randomised to the intervention arms will be recorded at the end of the study. Timeframe: 6 months 3. The distribution of visual acuity at the 3 and 6-month follow ups compared with visual acuity at the first visit in all 3 arms. Time frame: 6 months 4. The distribution of refractive outcomes (measured in dioptres) at 3 and 6-month follow ups as compared to the first visit in all 3 groups. Time frame: 6 months 5. Evidence of impaired emmetropisation following administration of FMT will be measured by combining refractive error and visual acuity measures. The trial will not be feasible if there is a 2SD difference without compensatory benefit eg 2 lines improvement in visual acuity. Timeframe: 6 months 6. The distribution of accommodative outcomes (measured in dioptres) at 3 and 6-month follow-ups as compared to the first visit in all 3 groups. Time frame: 6 months 7. Determination of appropriate resource-use data collection methods. A targeted paediatric CSRI form has been designed specifically for this population and will be used for the duration of the feasibility study. Time frame: 15 months 8. Proportion of families completing phone questionnaire on spectacle compliance as a percentage of those in the intervention groups (B1 & B2). Timeframe: 6 months 9. Significant mechanical trauma will be measured as the percentage of infants who have had an adverse event (from mechanical trauma) vs. the total number of infants prescribed glasses in groups B1 and B2. The study will not be feasible if this is more than 30% of infants in the intervention arms. Timeframe: 6 months 10. Consent rate - this will be measured as the number of | — |
Countries
England, United Kingdom
Contacts
Public ContactRaimonda;Richard Bullaj;Bowman
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Outcome results
None listed