NCT02490267

Brief Summary

The management of childhood glaucoma (CG), childhood cataract (CC) and other birth defects affecting the eyes requires frequent hospital attendances and often multiple surgical and medical interventions, and are often associated with poor vision. Chronic medical conditions and vision impairment can affect quality of life (QoL). The QoL of children with the above conditions has not previously been evaluated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 25, 2015

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 3, 2015

Completed
Last Updated

March 16, 2016

Status Verified

March 1, 2016

Enrollment Period

1.1 years

First QC Date

June 25, 2015

Last Update Submit

March 15, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Incidence of babies requiring treatment for retinopathy of prematurity in the UK.

    Captured in questionnaire

    1 year

Secondary Outcomes (3)

  • Demographic characteristics of babies that need treatment,

    1 year

  • Outcome of the treatment at 1 year follow up: anatomical and functional

    1 year

  • Type of treatment administered

    1 year

Study Arms (4)

1

children with primary or secondary glaucoma

Other: Quality of Life questionnaire

2

children w/ cataract or previously treated for cataract

Other: Quality of Life questionnaire

3

children w/ microphthalmia, anophthalmia or coloboma

Other: Quality of Life questionnaire

control group

age matched children without eye and vision problems.

Other: Quality of Life questionnaire

Interventions

123control group

Eligibility Criteria

Age2 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

We will recruit children who attend the children's eye clinics at Moorfields Eye Hospital at City Road. We will recruit children with healthy eyes and normal vision amongst the siblings who accompany new patients in Child Vision Clinics and the paediatric A\&E. This approach will ensure that families have not previously been burdened with frequent hospital appointments.

You may qualify if:

  • A) children with primary or secondary glaucoma B) children with cataract or previously treated for cataract C) children with microphthalmia, anophthalmia or coloboma D) control group: age-matched children without eye and vision problems

You may not qualify if:

  • Ocular hypertension not requiring treatment; visually not significant cataract; inability to communicate in English; surgical intervention (incisional) within one month of potential date of completing questionnaire (before or after)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moorfields Eye Hospital NHS Foundation Trust

London, London, EC1V 2PD, United Kingdom

Location

Study Officials

  • Annegret Dahlmann-Noor, Dr Med PhD

    Moorfields Eye Hospital NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2015

First Posted

July 3, 2015

Study Start

June 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

March 16, 2016

Record last verified: 2016-03

Locations