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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/21191443
Publication citations
-
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.