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Clinical Trials/NCT02490267
NCT02490267
Completed
Not Applicable

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

Moorfields Eye Hospital NHS Foundation Trust1 site in 1 country200 target enrollmentJune 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Paediatrics With Cataracts
Sponsor
Moorfields Eye Hospital NHS Foundation Trust
Enrollment
200
Locations
1
Primary Endpoint
Incidence of babies requiring treatment for retinopathy of prematurity in the UK.
Status
Completed
Last Updated
10 years ago

Overview

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.

Detailed Description

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).

Registry
clinicaltrials.gov
Start Date
June 2014
End Date
July 2015
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

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

Time Frame: 1 year

Captured in questionnaire

Secondary Outcomes

  • 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 Sites (1)

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