Primary Angle ClosureNCT00719290
Primary Angle Closure Glaucoma and Aqueous Dynamics
A study testing Phacoemulsification (Acrylic Foldable Intraocular Lens (Acrysoft)), (Healon5) and Phacoemulsification and goniosynechialysis (Acrylic Foldable Intraocular Lens (Acrysoft)), (Healon5) in people with Primary Angle Closure, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Primary Angle Closure
- What is being tested?
- Phacoemulsification (Acrylic Foldable Intraocular Lens (Acrysoft)), (Healon5) and Phacoemulsification and goniosynechialysis (Acrylic Foldable Intraocular Lens (Acrysoft)), (Healon5)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2008to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Primary Angle Closure
- Being tested
- Phacoemulsification (Acrylic Foldable Intraocular Lens (Acrysoft)), (Healon5), Phacoemulsification and goniosynechialysis (Acrylic Foldable Intraocular Lens (Acrysoft)), (Healon5)
- Keywords
- Primary Angle Closure Glaucoma, Phacoemulsification, Goniosynechialysis, Outflow facility
- Medical subject headings
- Glaucoma, Angle-Closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phacoemulsification (Acrylic Foldable Intraocular Lens (Acrysoft)), (Healon5)Procedure or surgery
Also called Healon5, Acrylic Foldable Intraocular Lens (Acrysoft)
Phacoemulsification of the lens with intraocular lens implant
Phacoemulsification and goniosynechialysis (Acrylic Foldable Intraocular Lens (Acrysoft)), (Healon5)Procedure or surgery
Also called Healon5, Acrylic Foldable Intraocular Lens (Acrysoft)
Phacoemulsification of the lens with intraocular lens implant and goniosynechialysis
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Phacoemulsification with intraocular lens implant alone Receives: Procedure: Phacoemulsification (Acrylic Foldable Intraocular Lens (Acrysoft)), (Healon5) |
| 2 | Active comparator | Phacoemulsification with intraocular lens implant and goniosynechialysis Receives: Procedure: Phacoemulsification and goniosynechialysis (Acrylic Foldable Intraocular Lens (Acrysoft)), (Healon5) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 3 months
Intra- or post operative complications
Measured: 2-3 weeks
Long-term PAS development
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Angle ClosureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KIN SHENG LIM, Guy's and St Thomas' NHS Foundation Trust
- Investigators
- K Sheng Lim, MB ChB MD FRCOpht, Principal investigator, Guys ans St Thomas' NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00719290
- Sponsor's protocol ID
- RJ1 08/0124
- Status last verified
- Aug 2015
- First submitted
- 17 Jul 2008
- Last updated
- 19 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28400374
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00719290
- Acronym / sponsor ID
- RJ1 08/0124
- Conditions
- Primary Angle Closure
- Keywords
- Primary Angle Closure Glaucoma, Phacoemulsification, Goniosynechialysis, Outflow facility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 21 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Phacoemulsification (Acrylic Foldable Intraocular Lens (Acrysoft)), (Healon5)Phacoemulsification with intraocular lens implant alone |
| 2 | Active comparator | Procedure: Phacoemulsification and goniosynechialysis (Acrylic Foldable Intraocular Lens (Acrysoft)), (Healon5)Phacoemulsification with intraocular lens implant and goniosynechialysis |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phacoemulsification (Acrylic Foldable Intraocular Lens (Acrysoft)), (Healon5)Also: Healon5, Acrylic Foldable Intraocular Lens (Acrysoft)Phacoemulsification of the lens with intraocular lens implant | Procedure or surgery | 1 |
| Phacoemulsification and goniosynechialysis (Acrylic Foldable Intraocular Lens (Acrysoft)), (Healon5)Also: Healon5, Acrylic Foldable Intraocular Lens (Acrysoft)Phacoemulsification of the lens with intraocular lens implant and goniosynechialysis | Procedure or surgery | 2 |
Primary outcome
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
3 secondary outcomes
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
Intra- or post operative complications
Time frame: 2-3 weeks
Long-term PAS development
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2015.
- Derived from this study: PubMed 28400374Rodrigues 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
K Sheng Lim, MB ChB MD FRCOpht principal investigator
Guys ans St Thomas' NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phacoemulsification (Acrylic Foldable Intraocular Lens (Acrysoft)), (Healon5) and Phacoemulsification and goniosynechialysis (Acrylic Foldable Intraocular Lens (Acrysoft)), (Healon5) in people with Primary Angle Closure, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00719290, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2015; AzTrials last refreshed its copy on 27 Oct 2026.