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

ISRCTN ISRCTN09311359
DOI https://doi.org/10.1186/ISRCTN09311359
Protocol serial number N/A
Sponsor Guy's and St. Thomas NHS Foundation Trust (UK)
Funder Eye Hope Charity (UK)
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

Primary study designObservational
Study designProspective observational longitudinal non-randomised study
Secondary study designNon randomised controlled trial
Study type Participant 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 measure(s)

Outflow facility determined
Comparison of results before and 3 months after treatment

Key secondary outcome measure(s)

1. Anterior chamber depth
2. Intraocular pressure
Comparison of results before and 3 months after treatment

Completion date31/05/2010

Eligibility

Participant type(s)Patient
Age groupOther
SexAll
Target sample size at registration60
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

  • United Kingdom
  • England

Study participating centre

St. Thomas' Hospital
London
SE1 7EH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot 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
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes