Clinical trial NCT02490267: Quality of Life in Children Glaucoma and Cataract
Official title: Health- and Vision-Related Quality of Life in Children and Young People With Childhood Glaucoma, Childhood Cataract and Congenital Eye Defects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Paediatrics With Cataracts
Paediatrics With Glaucoma
Lead sponsor: Moorfields Eye Hospital NHS Foundation Trust
Sponsor class: OTHER
First posted: 2015-07-03
Enrollment: 200
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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).

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)

Primary outcomes:
measure: Incidence of babies requiring treatment for retinopathy of prematurity in the UK.
timeFrame: 1 year
Secondary outcomes:
measure: Demographic characteristics of babies that need treatment,
timeFrame: 1 year
measure: Outcome of the treatment at 1 year follow up: anatomical and functional
timeFrame: 1 year
measure: Type of treatment administered
timeFrame: 1 year
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Moorfields Eye Hospital NHS Foundation Trust
Study officials:
affiliation: Moorfields Eye Hospital NHS Foundation Trust
name: Annegret Dahlmann-Noor, Dr Med PhD
role: PRINCIPAL_INVESTIGATOR
References: