Viscogonioplasty in narrow angle glaucoma

ISRCTN	ISRCTN83135049
DOI	https://doi.org/10.1186/ISRCTN83135049
Secondary identifying numbers	SLREC: 05/Q0904/111

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr Scott Fraser
Scientific

Sunderland Eye Infirmary
Queen Alexandra Road
Sunderland
SR2 9HP
United Kingdom

Email	scott.fraser@chs.northy.nhs.uk

Study design	Randomised single centre single-blind controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Evaluation of efficacy and safety of viscogonioplasty in narrow angle glaucoma: a randomised single blind single centre controlled trial
Study objectives	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(s)	Sunderland local research ethics committee (LREC) approved on the 21st February 2006 (ref: 05/Q0904/111)
Health condition(s) or problem(s) studied	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
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 study start date	01/02/2006
Completion date	01/02/2007

Participant type(s)	Patient
Age group	Other
Sex	Both
Target number of participants	34 patients
Key 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
Key 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
Date of first enrolment	01/02/2006
Date of final enrolment	01/02/2007

Sunderland Eye Infirmary

Sunderland
SR2 9HP
United Kingdom

City Hospitals Sunderland NHS Foundation Trust (UK)
Hospital/treatment centre

Kayll Road
Sunderland
SR2 7TP
England
United Kingdom

Phone	+44 (0)191 565 6256
Email	wendy.adams@chs.northy.nhs.uk
Website	http://www.sunderland.nhs.uk/chs/

Hospital/treatment centre

Sunderland Eye Infirmary (UK) - covered incidental costs

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	08/12/2010		Yes	No