Quality of Life in Children Glaucoma and Cataract

Completed

• Conditions: Paediatrics With Cataracts; Paediatrics With Glaucoma
• Interventions: Other: Quality of Life questionnaire

• Registration Number: NCT02490267
• Lead Sponsor: Moorfields Eye Hospital NHS Foundation Trust

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).

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2015-06-25
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Study First Submitted QC: 2015-07-01
• Study First Posted: 2015-07-03
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-15
• Last Update Posted: 2016-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
3	Quality of Life questionnaire	children w/ microphthalmia, anophthalmia or coloboma
1	Quality of Life questionnaire	children with primary or secondary glaucoma
2	Quality of Life questionnaire	children w/ cataract or previously treated for cataract
control group	Quality of Life questionnaire	age matched children without eye and vision problems.

Primary Outcome Measures

Name	Time	Method
Incidence of babies requiring treatment for retinopathy of prematurity in the UK.	1 year	Captured in questionnaire

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Moorfields Eye Hospital NHS Foundation Trust; 🇬🇧 London, United Kingdom