Primary Angle Closure Glaucoma and Aqueous Dynamics
A Randomised Comparative Study of the Effects of Cataract Extraction With Lens Implant Alone Versus Cataract Extraction With Lens Implant and Goniosynechialysis on Outflow Facility in Patients With Primary Angle Closure Glaucoma.
1 other identifier
interventional
24
1 country
1
Brief Summary
The aim of the study is to determine which is the best treatment for people with cataract and primary angle closure (PAC).In PAC, apposition of the iris tissue to the drainage channels (Trabecular Meshwork-TM) of the eye results in damage and formation of adherences between these structures (Peripheral anterior synaechiae-PAS) causing a mechanical obstruction of the aqueous outflow via the TM. It is thought that cataract surgery combined with mechanical separation of the iris from the TM with the breakage of PAS(we call this separation 'goniosynechialysis') would make the pressure even lower as it would cause the drain to open to a greater extent than cataract surgery alone. This technique is not new, and the results have been very encouraging. Comparing this technique to cataract surgery alone however, has not been done and this is exactly what we would like to do in order to help us decide what is the best treatment. In summary, the investigators propose that cataract surgery with goniosynechialysis would lower intraocular pressure to a greater extent than cataract surgery alone in patients with significant PAS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2008
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 17, 2008
CompletedFirst Posted
Study publicly available on registry
July 21, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedAugust 19, 2015
August 1, 2015
7.1 years
July 17, 2008
August 18, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
1. Outflow facility Success defined as increased outflow facility at 3 month compared to baseline with the same or reduced number of intraocular pressure lowering medications.
3 months
Secondary Outcomes (3)
1. Intraocular pressure Success defined as decreased IOP at 3 month compared to baseline with the same or reduced number of intraocular pressure lowering medications
3 months
Intra- or post operative complications
2-3 weeks
Long-term PAS development
1 year
Study Arms (2)
1
ACTIVE COMPARATORPhacoemulsification with intraocular lens implant alone
2
ACTIVE COMPARATORPhacoemulsification with intraocular lens implant and goniosynechialysis
Interventions
Phacoemulsification of the lens with intraocular lens implant
Phacoemulsification of the lens with intraocular lens implant and goniosynechialysis
Eligibility Criteria
You may qualify if:
- Age ≥ 21 years.
- Diagnosis of PAC or PACG. PACG is defined as glaucomatous optic neuropathy in the opinion of a fellowship-trained glaucoma specialist, together with an IOP \> 21mmHg on at least one occasion, and reproducible visual field defect (using the 24-2 test pattern on a Humphrey Field Analyser). PAC has all the above characteristics except for the visual field defect.
- More than 90 degrees of PAS (not necessarily contiguous).
- Lens opacity deemed sufficient to be causing decreased vision in the opinion of the supervising consultant (KSL).
- Ability to give informed consent.
You may not qualify if:
- Previous intraocular surgery or keratorefractive surgery.
- Previous eye trauma resulting in documented damage to the drainage angle (such as angle recession).
- History of uveitis.
- For patients on warfarin, INR \>3.0 on day of surgery.
- Anterior segment neovascularisation.
- Chronic use of topical or systemic steroids.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St Thomas' Hospital
London, SE1 7EH, United Kingdom
Related Publications (1)
Rodrigues IA, Alaghband P, Beltran Agullo L, Galvis E, Jones S, Husain R, Lim KS. Aqueous outflow facility after phacoemulsification with or without goniosynechialysis in primary angle closure: a randomised controlled study. Br J Ophthalmol. 2017 Jul;101(7):879-885. doi: 10.1136/bjophthalmol-2016-309556. Epub 2016 Oct 17.
PMID: 28400374DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
K Sheng Lim, MB ChB MD FRCOpht
Guys ans St Thomas' NHS Trust
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant Ophthalmic Surgeon
Study Record Dates
First Submitted
July 17, 2008
First Posted
July 21, 2008
Study Start
July 1, 2008
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
August 19, 2015
Record last verified: 2015-08