Quality of Life in Children Glaucoma and Cataract

• Sponsor: Moorfields Eye Hospital NHS Foundation Trust (Other)
• Overall Status: Completed
• CT.gov ID: NCT02490267
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Duration (Months): 13
• Patients Per Site Per Month: 15.4

Study Details

Study Description

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	Phase
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:

1. 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 Design

• 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: Jun 1, 2014
• Actual Primary Completion Date: Jul 1, 2015
• Actual Study Completion Date: Jul 1, 2015

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Incidence of babies requiring treatment for retinopathy of prematurity in the UK. [1 year]

   Captured in questionnaire

Secondary Outcome Measures

1. Demographic characteristics of babies that need treatment, [1 year]

   Captured in questionnaire

2. Outcome of the treatment at 1 year follow up: anatomical and functional [1 year]

   Captured in questionnaire

3. Type of treatment administered [1 year]

   Captured in questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 16 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Moorfields Eye Hospital NHS Foundation Trust	London		United Kingdom	EC1V 2PD

Sponsors and Collaborators

• Moorfields Eye Hospital NHS Foundation Trust

Investigators

• Principal Investigator: Annegret Dahlmann-Noor, Dr Med PhD, Moorfields Eye Hospital NHS Foundation Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Moorfields Eye Hospital NHS Foundation Trust
• ClinicalTrials.gov Identifier: NCT02490267
• Other Study ID Numbers: DALA1020
• First Posted: Jul 3, 2015
• Last Update Posted: Mar 16, 2016
• Last Verified: Mar 1, 2016

• Additional relevant MeSH terms: Glaucoma; Cataract

Study Results

No Results Posted as of Mar 16, 2016