Babies in Glasses; a Feasibility Study.

Summary

This is a feasibility study to begin investigating the possibility that early use of near vision glasses will improve vision in infants at risk of Cerebral Visual Impairment (CVI), leading to further improvement in other areas of development. This active intervention, starting at either 2 or 4 months of age (depending on randomisation), could be more effective than waiting until a problem is detected before giving glasses.

As this is a feasibility study, the investigators are looking at a small sample of babies (n=75) to see whether their parents/carers are willing to take part in a 3-arm study comparing two differently timed interventions to a control group, as well as looking at different aspects of the research plan in preparation for a larger final study.

Conditions

• Cerebral Visual Impairment
• Refractive and Accommodative Disorders
• Hypoxic-Ischemic Encephalopathy
• Premature Birth

Interventions

DEVICE

Near vision spectacles

Near vision spectacles prescribed for full time wear (Add+3.00DS to the full cycloplegic refraction). These glasses will be changed to reflect changes in refractive error or frame fit as appropriate at follow up.

Sponsors & Collaborators

• National Institute for Health Research, United Kingdom

  collaborator OTHER_GOV

• University College London Hospitals

  collaborator OTHER

• University College, London

  collaborator OTHER

• University of Reading

  collaborator OTHER

• University of Bristol

  collaborator OTHER

• University of Ulster

  collaborator OTHER

• Great Ormond Street Hospital for Children NHS Foundation Trust

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

8 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-09-09

Primary Completion

2023-06-09

Completion

2023-12-31

Countries

• United Kingdom

Study Locations