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Primary Angle Closure Glaucoma and Aqueous Dynamics

Primary Purpose

Primary Angle Closure

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Phacoemulsification (Acrylic Foldable Intraocular Lens (Acrysoft)), (Healon5)
Phacoemulsification and goniosynechialysis (Acrylic Foldable Intraocular Lens (Acrysoft)), (Healon5)
Sponsored by
Guy's and St Thomas' NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Angle Closure focused on measuring Primary Angle Closure Glaucoma, Phacoemulsification, Goniosynechialysis, Outflow facility

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • St Thomas' Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Phacoemulsification with intraocular lens implant alone

Phacoemulsification with intraocular lens implant and goniosynechialysis

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Intra- or post operative complications
Long-term PAS development

Full Information

First Posted
July 17, 2008
Last Updated
August 18, 2015
Sponsor
Guy's and St Thomas' NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT00719290
Brief Title
Primary Angle Closure Glaucoma and Aqueous Dynamics
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guy's and St Thomas' NHS Foundation Trust

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Angle Closure
Keywords
Primary Angle Closure Glaucoma, Phacoemulsification, Goniosynechialysis, Outflow facility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Phacoemulsification with intraocular lens implant alone
Arm Title
2
Arm Type
Active Comparator
Arm Description
Phacoemulsification with intraocular lens implant and goniosynechialysis
Intervention Type
Procedure
Intervention Name(s)
Phacoemulsification (Acrylic Foldable Intraocular Lens (Acrysoft)), (Healon5)
Other Intervention Name(s)
Healon5, Acrylic Foldable Intraocular Lens (Acrysoft)
Intervention Description
Phacoemulsification of the lens with intraocular lens implant
Intervention Type
Procedure
Intervention Name(s)
Phacoemulsification and goniosynechialysis (Acrylic Foldable Intraocular Lens (Acrysoft)), (Healon5)
Other Intervention Name(s)
Healon5, Acrylic Foldable Intraocular Lens (Acrysoft)
Intervention Description
Phacoemulsification of the lens with intraocular lens implant and goniosynechialysis
Primary Outcome Measure Information:
Title
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
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
Time Frame
3 months
Title
Intra- or post operative complications
Time Frame
2-3 weeks
Title
Long-term PAS development
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
K Sheng Lim, MB ChB MD FRCOpht
Organizational Affiliation
Guys ans St Thomas' NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Thomas' Hospital
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
28400374
Citation
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.
Results Reference
derived

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Primary Angle Closure Glaucoma and Aqueous Dynamics

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