Babies in Glasses; a Feasibility Study.

NCT05048550 | Unknown DMC

• 1 other identifier: 18BA36
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cerebral Visual Impairment; CVI; Visual Processing Disorder; Visual Perceptual Deficits; VPD; Accommodative Disorders; Hypo-accommodation; Accommodative lag; Hypoxic Ischaemic Encephalopathy; Premature Birth; Near Vision Glasses; Spectacle correction; Refractive correction; Refractive Error; Early spectacle correction; Spectacles; Glasses; Perinatal Brain Insult; Brain Injury; Neurodevelopment; Infant; Baby; Functional broadband Near Infrared Spectroscopy; fBNIRS

Outcome Measures

Primary Outcomes (1)

• The acceptance of randomisation

  This will be measured as the proportion of patients/parents who accept the offer of randomisation.

  10 months

Secondary Outcomes (11)

• Success rate in dispensing glasses to children in groups B1 and B2.

  6 months

• Success rate of compliance with glasses for infants in groups B1 and B2.

  6 months

• Visual Acuity

  6 months

• Retention rate

  15 months

• Refractive outcomes

  6 months

Study Arms (3)

A (control)

NO INTERVENTION

First visit assessments at 8 weeks corrected gestational age. No glasses prescribed.

B1 (intervention)

EXPERIMENTAL

First visit assessments at 8 weeks corrected gestational age. Full time spectacle wear prescribed.

Device: Near vision spectacles

B2 (intervention)

EXPERIMENTAL

First visit assessments at 16 weeks corrected gestational age. Full time spectacle wear prescribed.

Device: Near vision spectacles

Interventions

Near vision spectacles DEVICE

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.

B1 (intervention); B2 (intervention)

Eligibility Criteria

• Age: Up to 8 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All term infants undergoing therapeutic hypothermia for hypoxic ischaemic encephalopathy (HIE).
• All preterm infants born at \<29 weeks gestational age.
• Specifically, all children fulfilling these criteria will be eligible. Evidence of hypo-accommodation is not required.

You may not qualify if:

• Infants that are still an inpatient at 8 weeks corrected gestational age.
• Infants with high refractive error (more than -6.00D spherical equivalent or +8.00D spherical equivalent).

Sponsors & Collaborators

• Great Ormond Street Hospital for Children NHS Foundation Trust: lead
• National Institute for Health Research, United Kingdom: collaborator
• University College London Hospitals: collaborator
• University College, London: collaborator
• University of Reading: collaborator
• University of Bristol: collaborator
• University of Ulster: collaborator

Study Sites (1)

University College London Hospital

London, WC1E 6DB, United Kingdom

Location

Related Publications (1)

• Bullaj R, Dyet L, Mitra S, Bunce C, Clarke CS, Saunders K, Dale N, Horwood A, Williams C, St Clair Tracy H, Marlow N, Bowman R. Effectiveness of early spectacle intervention on visual outcomes in babies at risk of cerebral visual impairment: a parallel group, open-label, randomised clinical feasibility trial protocol. BMJ Open. 2022 Sep 21;12(9):e059946. doi: 10.1136/bmjopen-2021-059946.

  PMID: 36130761 DERIVED

MeSH Terms

Conditions

Blindness, Cortical; Hypoxia-Ischemia, Brain; Premature Birth; Refractive Errors; Brain Injuries

Condition Hierarchy (Ancestors)

Blindness; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single-centre randomised interventional study; a 3-arm parallel group, open-label clinical feasibility trial for a definitive RCT with equal arm allocation and a superiority design.

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: September 17, 2021
• Study Start: September 9, 2021
• Primary Completion: June 9, 2023
• Study Completion: December 31, 2023
• Last Updated: September 29, 2022

Record last verified: 2022-09

Locations

GB (1)