Quality of Life in Children Glaucoma and Cataract

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

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.

Study Overview

• Status: Completed
• Conditions: Paediatrics With Cataracts; Paediatrics With Glaucoma
• Intervention / Treatment: Other: Quality of Life questionnaire

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).

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, EC1V 2PD
    • Moorfields Eye Hospital NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of babies requiring treatment for retinopathy of prematurity in the UK.	Captured in questionnaire	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic characteristics of babies that need treatment,	Captured in questionnaire	1 year
Outcome of the treatment at 1 year follow up: anatomical and functional	Captured in questionnaire	1 year
Type of treatment administered	Captured in questionnaire	1 year

Collaborators and Investigators

• Sponsor: Moorfields Eye Hospital NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: June 25, 2015
• First Submitted That Met QC Criteria: July 1, 2015
• First Posted (Estimate): July 3, 2015

Study Record Updates

• Last Update Posted (Estimate): March 16, 2016
• Last Update Submitted That Met QC Criteria: March 15, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Lens Diseases; Glaucoma; Cataract
• Other Study ID Numbers: DALA1020