Condition category
Eye Diseases
Date applied
07/12/2009
Date assigned
02/02/2010
Last edited
11/07/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Kin Sheng Lim

ORCID ID

Contact details

St. Thomas' Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom
+44 (0)20 7188 2289
shenglim@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The contribution of race as a determining factor in the development of Primary Open Angle Glaucoma (POAG): An observational trial

Acronym

ADS (aqueous dynamic study)

Study hypothesis

The 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

St. Thomas' Hospital Research Ethics Committee, Approved on 14 August 2007, REC ref number: 07/Q0702/61

Study design

Prospective observational longitudinal non-randomised study

Primary study design

Observational

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

Primary open angle glaucoma (POAG)

Intervention

Patients 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 type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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

Secondary outcome measures

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

Overall trial start date

15/10/2007

Overall trial end date

31/05/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. 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

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

30 patients from each of the following race groups with or without POAG: African origin and White Caucasian

Participant exclusion criteria

1. History of intraocular surgery or keratorefractive surgery
2. Systemic medications which affects aqueous production, such as beta adrenergic blockers, steroids
3. Fluorescein allergy

Recruitment start date

15/10/2007

Recruitment end date

31/05/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St. Thomas' Hospital
London
SE1 7EH
United Kingdom

Sponsor information

Organisation

Guy's and St. Thomas NHS Foundation Trust (UK)

Sponsor details

c/o Karen Ignatian
Research and Development
3rd Floor Conybeare House
Guy's House
Guy's Hospital
St .Thomas Street
London
SE1 9RT
United Kingdom
+44 (0)20 7188 5731
karen.ignatian@gstt.nhs.uk

Sponsor type

Hospital/treatment centre

Website

http://www.guysandstthomas.nhs.uk/

Funders

Funder type

Charity

Funder name

Eye Hope Charity (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21980001

Publication citations

  1. Results

    Beltran-Agullo L, Alaghband P, Rashid S, Gosselin J, Obi A, Husain R, Lim KS, Comparative human aqueous dynamics study between black and white subjects with glaucoma., Invest. Ophthalmol. Vis. Sci., 2011, 52, 13, 9425-9430, doi: 10.1167/iovs.10-7130.

Additional files

Editorial Notes