The contribution of race as a determining factor in the development of glaucoma

ISRCTN ISRCTN09311359
DOI https://doi.org/10.1186/ISRCTN09311359
Secondary identifying numbers N/A
Submission date
07/12/2009
Registration date
02/02/2010
Last edited
11/07/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Kin Sheng Lim
Scientific

St. Thomas' Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom

Phone +44 (0)20 7188 2289
Email shenglim@gmail.com

Study information

Study designProspective observational longitudinal non-randomised study
Primary study designObservational
Secondary study designNon randomised controlled trial
Study setting(s)Hospital
Study typeOther
Participant information sheet Not available in web format, please use contact details below to request a patient information sheet
Scientific titleThe contribution of race as a determining factor in the development of Primary Open Angle Glaucoma (POAG): An observational trial
Study acronymADS (aqueous dynamic study)
Study objectivesThe distribution of aqueous production rate and the out-flow facility in patients from different racial groups with POAG.

Primary open angle glaucoma is defined as glaucomatous optic neuropathy together with an IOP >21 mmHg on at least one occasion and visual field defects (using the 24-2 test pattern on a Humphrey Field Analyzer) and a gonioscopic angle width of 3 or 4 and normal in appearance.
Ethics approval(s)St. Thomas' Hospital Research Ethics Committee, Approved on 14 August 2007, REC ref number: 07/Q0702/61
Health condition(s) or problem(s) studiedPrimary open angle glaucoma (POAG)
InterventionPatients will receive standard treatment and care. Therefore, there is no intervention, just some extra measurements which used to be part of routine clinical examinations.
Additional measurements will be carried out using pnuematonometry, fluorophotometry and Schiotz tonography machines
Intervention typeOther
Primary outcome measureOutflow facility determined
Comparison of results before and 3 months after treatment
Secondary outcome measures1. Anterior chamber depth
2. Intraocular pressure
Comparison of results before and 3 months after treatment
Overall study start date15/10/2007
Completion date31/05/2010

Eligibility

Participant type(s)Patient
Age groupOther
SexBoth
Target number of participants30 patients from each of the following race groups with or without POAG: African origin and White Caucasian
Key inclusion criteria1. Males or Females between ages 18 and 90
2. Availability to participate in all aspects of the study
3. Willingness to participate in a study
4. Ability to undergo accurate fluorophotometry and tonography
Key exclusion criteria1. History of intraocular surgery or keratorefractive surgery
2. Systemic medications which affects aqueous production, such as beta adrenergic blockers, steroids
3. Fluorescein allergy
Date of first enrolment15/10/2007
Date of final enrolment31/05/2010

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

St. Thomas' Hospital
London
SE1 7EH
United Kingdom

Sponsor information

Guy's and St. Thomas NHS Foundation Trust (UK)
Hospital/treatment centre

c/o Karen Ignatian
Research and Development
3rd Floor Conybeare House
Guy's House
Guy's Hospital
St .Thomas Street
London
SE1 9RT
England
United Kingdom

Phone +44 (0)20 7188 5731
Email karen.ignatian@gstt.nhs.uk
Website http://www.guysandstthomas.nhs.uk/
ROR logo "ROR" https://ror.org/00j161312

Funders

Funder type

Charity

Eye Hope Charity (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 09/12/2011 Yes No