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Quality of Life in Children Glaucoma and Cataract

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ClinicalTrials.gov Identifier: NCT02490267
Recruitment Status : Completed
First Posted : July 3, 2015
Last Update Posted : March 16, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Paediatrics With Cataracts Paediatrics With Glaucoma 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).


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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Health- and Vision-Related Quality of Life in Children and Young People With Childhood Glaucoma, Childhood Cataract and Congenital Eye Defects
Study Start Date : June 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Glaucoma

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



Primary Outcome Measures :
  1. Incidence of babies requiring treatment for retinopathy of prematurity in the UK. [ Time Frame: 1 year ]
    Captured in questionnaire


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02490267


Locations
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United Kingdom
Moorfields Eye Hospital NHS Foundation Trust
London, United Kingdom, EC1V 2PD
Sponsors and Collaborators
Moorfields Eye Hospital NHS Foundation Trust
Investigators
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Principal Investigator: Annegret Dahlmann-Noor, Dr Med PhD Moorfields Eye Hospital NHS Foundation Trust

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Responsible Party: Moorfields Eye Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02490267     History of Changes
Other Study ID Numbers: DALA1020
First Posted: July 3, 2015    Key Record Dates
Last Update Posted: March 16, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
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Glaucoma
Cataract
Ocular Hypertension
Eye Diseases
Lens Diseases