Paediatrics With CataractsNCT02490267
Quality of Life in Children Glaucoma and Cataract
An observational study of Paediatrics With Cataracts and Paediatrics With Glaucoma, run by Moorfields Eye Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Paediatrics With Cataracts, Paediatrics With Glaucoma
- What is being tested?
- Quality of Life questionnaire
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2014to Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 16 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Moorfields Eye Hospital NHS Foundation Trust
London, London, EC1V 2PD
About this study
Official title: 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.
Read the 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:
- 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).
- Being tested
- Quality of Life questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of Life questionnaireOther
| Study group | Role | What they receive |
|---|---|---|
| 1 | children with primary or secondary glaucoma Receives: Other: Quality of Life questionnaire | |
| 2 | children w/ cataract or previously treated for cataract Receives: Other: Quality of Life questionnaire | |
| 3 | children w/ microphthalmia, anophthalmia or coloboma Receives: Other: Quality of Life questionnaire | |
| control group | age matched children without eye and vision problems. Receives: Other: Quality of Life questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of babies requiring treatment for retinopathy of prematurity in the UK.
Captured in questionnaire
Measured: 1 year
Secondary outcomes (3)
Demographic characteristics of babies that need treatment,
Captured in questionnaire
Measured: 1 year
Outcome of the treatment at 1 year follow up: anatomical and functional
Captured in questionnaire
Measured: 1 year
Type of treatment administered
Captured in questionnaire
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2015 (estimated)
- Study startJun 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paediatrics With CataractsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Annegret Dahlmann-Noor, Dr Med PhD, Principal investigator, Moorfields Eye Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02490267
- Sponsor's protocol ID
- DALA1020
- Status last verified
- Mar 2016
- First submitted
- 25 Jun 2015
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health- and Vision-Related Quality of Life in Children and Young People With Childhood Glaucoma, Childhood Cataract and Congenital Eye Defects
- ClinicalTrials.gov ID
- NCT02490267
- Acronym / sponsor ID
- DALA1020
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation TrustUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 3 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Quality of Life questionnairechildren with primary or secondary glaucoma |
| 2 | – | Other: Quality of Life questionnairechildren w/ cataract or previously treated for cataract |
| 3 | – | Other: Quality of Life questionnairechildren w/ microphthalmia, anophthalmia or coloboma |
| control group | – | Other: Quality of Life questionnaireage matched children without eye and vision problems. |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality of Life questionnaire | Other | 1, 2, 3, control group |
Primary outcome
Incidence of babies requiring treatment for retinopathy of prematurity in the UK.
Time frame: 1 year
Captured in questionnaire
3 secondary outcomes
Demographic characteristics of babies that need treatment,
Time frame: 1 year
Outcome of the treatment at 1 year follow up: anatomical and functional
Time frame: 1 year
Type of treatment administered
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annegret Dahlmann-Noor, Dr Med PhD principal investigator
Moorfields Eye Hospital NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Paediatrics With Cataracts and Paediatrics With Glaucoma, run by Moorfields Eye Hospital NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of babies requiring treatment for retinopathy of prematurity in the UK. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2016.