Condition category
Eye Diseases
Date applied
08/02/2010
Date assigned
14/04/2010
Last edited
15/07/2013
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 Scott Fraser

ORCID ID

Contact details

Sunderland Eye Infirmary
Queen Alexandra Road
Sunderland
SR2 9HP
United Kingdom
scott.fraser@chs.northy.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SLREC: 05/Q0904/111

Study information

Scientific title

Evaluation of efficacy and safety of viscogonioplasty in narrow angle glaucoma: a randomised single blind single centre controlled trial

Acronym

Study hypothesis

Viscogonioplasty combined with cataract surgery in patients with narrow angle glaucoma will have a greater effect on intraocular pressure than cataract surgery alone.

Ethics approval

Sunderland local research ethics committee (LREC) approved on the 21st February 2006 (ref: 05/Q0904/111)

Study design

Randomised single centre single-blind controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Narrow angle glaucoma

Intervention

Cataract surgery combined with viscogonioplasty or cataract surgery alone. Follow-up of the patients intraocular pressure was for 12 months post-operation with a clinic visit at 3, 6 and 12 months.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Intraocular pressure lowering following cataract surgery and viscogonioplasty versus catarct surgery alone, measured at 12 months

Secondary outcome measures

1. Opening of drainage angle when examined on gonioscopy, measured at 12 months
2. Complications following viscogonioplasty, measured immediately following surgery

Overall trial start date

01/02/2006

Overall trial end date

01/02/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with evidence of glaucoma, presence of a narrow drainage angle defined as:
1.1. Less than 90 degrees of the trabecular meshwork visible on gonioscopy
1.2. Previous patent laser peripheral iridotomy
1.3. Presence of cataract
2. Any age, any gender

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

34 patients

Participant exclusion criteria

1. Plateau iris syndrome
2. Other glaucomas
3. Previous glaucoma surgery
4. History of ocular injury
5. Participation in any other glaucoma research

Recruitment start date

01/02/2006

Recruitment end date

01/02/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Sunderland Eye Infirmary
Sunderland
SR2 9HP
United Kingdom

Sponsor information

Organisation

City Hospitals Sunderland NHS Foundation Trust (UK)

Sponsor details

Kayll Road
Sunderland
SR2 7TP
United Kingdom
+44 (0)191 565 6256
wendy.adams@chs.northy.nhs.uk

Sponsor type

Government

Website

http://www.sunderland.nhs.uk/chs/

Funders

Funder type

Hospital/treatment centre

Funder name

Sunderland Eye Infirmary (UK) - covered incidental costs

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

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/21191443

Publication citations

  1. Results

    Varma D, Adams W, Bunce C, Phelan P, Fraser S, Viscogonioplasty in narrow angle glaucoma: a randomized controlled trial., Clin Ophthalmol, 2010, 4, 1475-1479, doi: 10.2147/OPTH.S15447.

Additional files

Editorial Notes