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OpenTrials
Completed

NCT Number: NCT02490267

Quality of Life in Children Glaucoma and Cataract

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.

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Key information

Age range

2 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Moorfields Eye Hospital NHS Foundation Trust

London, EC1V 2PD, United Kingdom

About this study

We wish to evaluate health related and vision related quality of life (HRQoL, VRQoL) in children age 2 to 16 years with childhood glaucoma (CG), childhood cataract (CC) and congenital eye defects microphthalmia, anophthalmia or coloboma (MAC).

We will recruit children who attend the children's eye clinics at Moorfields Eye Hospital at City Road. We will include the following subgroups:

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: agematched children without eye and vision problems. We will ask children and their carers to complete two age appropriate, validated questionnaires, the PedsQL (health related quality of life) and the Cardiff Visual Ability Questionnaire for Children. From the medical notes, we will record diagnosis and best corrected visual acuity with both eyes open. We will also record details of previous and current treatment, such as number of previous surgical interventions (sum of interventions right and left eye) and number of current topical medications (sum of eyedrop applications per day right and left eye).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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)

Treatment and study plan

Quality of Life Questionnaire

Other

Primary outcomes

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

    Time frame: 1 year

    Captured in questionnaire

Secondary outcomes

  1. Demographic characteristics of babies that need treatment,

    Time frame: 1 year

    Captured in questionnaire

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

    Time frame: 1 year

    Captured in questionnaire

  3. Type of treatment administered

    Time frame: 1 year

    Captured in questionnaire

Sponsors and collaborators

Lead sponsor

Moorfields Eye Hospital NHS Foundation Trust

Other

Registry information

Official study title

Health- and Vision-Related Quality of Life in Children and Young People With Childhood Glaucoma, Childhood Cataract and Congenital Eye Defects

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 3, 2015
Registry last updated
Mar 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.