Primary Open Angle GlaucomaPEACENCT02989207
Surgical Approaches in Treating Uncontrolled Glaucoma in Black African and African-Caribbeans
A study testing Trabeculectomy, Baerveldt tube surgery and mitomycin-C in people with Primary Open Angle Glaucoma, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The aim is to perform a randomised feasibility trial preceding a large prospective randomised controlled trial (RCT) comparing three surgical methods - trabeculectomy with Mitomycin C (MMC), primary Baerveldt tube with MMC and Baerveldt tube without MMC - in black African/African Caribbean patients with Primary Open… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Primary Open Angle Glaucoma
- What is being tested?
- Trabeculectomy, Baerveldt tube surgery and mitomycin-C
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2016to Dec 2017
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to understand the information sheet and give informed consent.
- Black African Caribbean or African (defined as a person having origins in any of the black racial groups of Africa). The identification of African or African-Caribbean ethnicity will be based on patients' self-reported ethnicity classification in their NHS case notes. In our recent audit, almost 90% of the case notes had data on patients' self-reported ethnicity.
- Age 18 to 85 years, inclusive. Inclusion criteria for study eye
- All of the criteria listed below must be present in the study eye in order for the patient to be eligible for enrolment in the study:
- Glaucoma that is uncontrolled on tolerated medical therapy with IOP ≥18 mmHg and ≤40 mmHg in the study eye.
- No previous incisional ocular surgery in the study eye except for: i) Clear corneal phacoemulsification surgery. ii) Previous conjunctival sparing minimally invasive glaucoma surgeries (MIGS) more than 6 months ago. This may include procedures that do not involve the conjunctiva such as Hydrus Microstent, iStent and endoscopic cyclophotocoagulation (ECP) laser.
- The authors do not think it likely that pseudophakia will influence the outcomes but randomisation will be stratified by lens status to ensure balance in the treatment arms.
Who cannot join
- General Exclusion Criteria
- Patients are ineligible to participate in the study where any of the following criteria apply:
- Any inclusion criteria not met.
- Pregnant or nursing women (or planning pregnancy).
- Unwilling or unable to give informed consent, unwilling to accept randomisation, or unable to return for scheduled protocol visits.
- Ongoing participation in other interventional clinical trials. Exclusion criteria for study eye
Show all 21Show fewer
- The patient may not be entered into the study if any of the following exclusion criteria are present in the study eye:
- No light perception vision.
- Active diabetic retinopathy.
- Secondary glaucomas.
- Unwilling to discontinue contact lens use after surgery.
- Conjunctival scarring from prior ocular trauma or cicatrizing disease (e.g. Stevens Johnson syndrome, ocular pemphigoid) precluding a superior trabeculectomy.
- Functionally significant cataract likely to require surgery within 6 months of glaucoma surgery.
- Previous complicated cataract surgery in the study eye.
- Need for glaucoma surgery combined with other ocular procedures (i.e. cataract surgery, penetrating keratoplasty, or retinal surgery) or anticipated need for additional ocular surgery.
- Iris neovascularization or proliferative retinopathy.
- Iridocorneal endothelial syndrome.
- Epithelial or fibrous downgrowth.
- Chronic or recurrent uveitis.
- Steroid-induced glaucoma.
- Severe posterior blepharitis.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
St Thomas Hospital
London, SE1 7EH
K Sheng Lim, MD, +442071884885, shenglim@gmail.com
Stephanie Jones, BSc, +442071884885, stephanie.jones@gsst.nhs.uk
About this study
Official title: Comparing Surgical Approaches to Treat Black African and Africa-Caribbean Patients With Uncontrolled Primary Open Angle Glaucoma: A Randomised Feasibility Study
The aim is to perform a randomised feasibility trial preceding a large prospective randomised controlled trial (RCT) comparing three surgical methods - trabeculectomy with Mitomycin C (MMC), primary Baerveldt tube with MMC and Baerveldt tube without MMC - in black African/African Caribbean patients with Primary Open Angle Glaucoma (POAG) living in London.
The UK Office of National Statistics estimated that among the population of England in 2007, approximately 4.3% were of African/African-Caribbean background, while in large cities such as London and Birmingham about 20% of the population is of African/African-Caribbean origin. For eye units in these cities, managing glaucoma in this population is challenging and we need to identify a better alternative to our current standard surgical treatment.
Read more
There is now evidence from one RCT which shows better overall outcomes from tube surgery in comparison to trabeculectomy for glaucoma. However, this study did not address black populations specifically and did not address the potential role of MMC in tube surgery.
This feasibility study will enable us to design a fully powered RCT with the aim of determining how best to optimise the surgical treatment of POAG in black populations, by comparing outcomes in three types of glaucoma surgery.
Read the detailed description
An audit performed at St Thomas's Hospital in 2008 showed that 52 trabeculectomy and 50 Baerveldt tube procedures were done in one year, with 60% of the patients being of 'black' ethnicity. This audit provides the basis for teh recruitment target. Assuming that the majority of the trabeculectomies performed were for POAG then most of these 'black' patients would have been eligible for the trial.
Primary Tube versus Trabeculectomy Study (PTVT) St Thomas' Hospital is the leading recruiting centre for this multinational study. The investigators have recruited over 50 patients in the last 2 years despite the lack of a dedicated research team. The trial retention rate has also been very good with less than 5% loss to follow-up rates.
Patient Feedback and Involvement The proposed research was reviewed in a feedback session in 2012 with 5 black African-Caribbean/African patients with glaucoma attending St Thomas' Hospital. All were very positive about the potential trial and all understood that there is a 'unique' problem for glaucoma surgery in this group of patients. Suggestions for the trial included more emphasis on the importance of treatment for glaucoma, disseminating information about the trial in community centres, and the possibility of expert patients who can act as patient advocates and help with recruitment in the glaucoma clinics and present the study in local community centres.
Feasibility study This protocol is for a randomised feasibility trial which will compare standard treatment (trabeculectomy with MMC) with primary Baerveldt tube surgery with or without MMC in black African/African-Caribbean patients with POAG living in London. The study will look at the feasibility of recruitment for a proposed larger scale RCT and will also help the investigators to refine the methodology for the proposed trial in terms of outcome measures and analysis. It will also help the investigators to recruit a patient user group for input into the conduct and monitoring of the main trial.
Information the study will provide
The investigators are conducting this feasibility study in order to get an estimate of the likely recruitment rate for the main study and to collect information that will help the investigators to refine the outcome measures for the main study and to allow a valid calculation of the sample size needed for a definitive study to answer the primary research question. The investigators will use questionnaires to gather data on patients' quality of life for health economic analysis but it is also our hope that the questionnaires will give the investigators information on the perspectives of patients, including their preferences. This feasibility study will help the investigators to explore how they can gather useful information on the patient perspective.
The feasibility study will also inform their planning for the main trial and data management and help them to develop their community engagement and recruitment strategies, including theri strategy for publicising the trial and enhancing recruitment. In addition, the investigators intend to use the feasibility study to recruit a patient representative group for input into the conduct and monitoring of the proposed main study.
Risks and benefits The potential risks and benefits for patients participating in the feasibility study are similar to those for standard clinical care. All participants will have been identified as in need of glaucoma drainage surgery. Both trabeculectomy (currently as first line treatment) and Baerveldt tube surgery (currently as second line treatment) are in routine use for the treatment of POAG. Evidence on the beneficial effect of MMC is equivocal. First line treatment with Baerveldt tube surgery may be associated with less failure and complications than first line treatment by trabeculectomy but there is as yet no definitive evidence on this question that is specific to the population included in this study.
- Conditions
- Primary Open Angle Glaucoma
- Being tested
- Trabeculectomy, Baerveldt tube surgery, mitomycin-C
- Keywords
- Glaucoma, Trabeculectomy, Glaucoma drainage implant, Africa and Africa-Caribbean
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrabeculectomyProcedure or surgery
Also called Trabeculectomy with Mitomycin-C
The current standard surgical treatment for glaucoma remains trabeculectomy. Wound healing modulation with antifibrotic agents, like MMC and 5-fluorouracil (5-FU), has been shown to increase the success of glaucoma filtering surgery in high-risk eyes
Baerveldt tube surgeryDevice
Also called Baerveldt tube surgery with Mitomycin C
All glaucoma drainage devices consist of a tube which is inserted into the anterior chamber of the eye, draining aqueous humour to a plate which maintains a minimum bleb size and allows the collection of aqueous humour to be absorbed into the surrounding tissue.
mitomycin-CDrug
This is an anti scarring agent whcih is an standard adjunctive treatment in glaucoma surgery
| Study group | Role | What they receive |
|---|---|---|
| Trabeculectomy with Mitomycin-C | Active comparator | The current standard surgical treatment for glaucoma remains trabeculectomy. Receives: Procedure: Trabeculectomy; Drug: mitomycin-C |
| Baerveldt tube surgery with Mitomycin C | Active comparator | It consists of a tube, draining aqueous humour to a plate Receives: Device: Baerveldt tube surgery; Drug: mitomycin-C |
| Baerveldt tube surgery without Mitomycin C | Active comparator | It consists of a tube, draining aqueous humour to a plate Receives: Device: Baerveldt tube surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate:
The number of potential participants enrolled over a set time
Measured: 6 months
Secondary outcomes (6)
Success rate
Eyes that have not failed and are not on supplemental medical therapy are considered complete successes
Measured: 6 months
Failure rate
- IOP >21 mmHg or not reduced by 20% below baseline on two consecutive follow-up visits
- Additional glaucoma surgery
- Loss of vision.
- IOP <5 mmHg on two consecutive follow-up visits
Measured: 6 months
Complication rate
Measured: 6 months
The number of extra unscheduled clinic visits and unplanned procedures
Measured: 6 months
Loss to follow-up rate
Measured: 6 months
Response rates to the self-report
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open Angle GlaucomaStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- 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
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- K Sheng Lim, MD, Principal investigator, Guy's and St Thomas NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02989207
- Sponsor's protocol ID
- 160807
- Other IDs
- 15/LO/1810
- Acronym
- PEACE
- Status last verified
- Dec 2016
- First submitted
- 2 Dec 2016
- Last updated
- 12 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Surgical Approaches to Treat Black African and Africa-Caribbean Patients With Uncontrolled Primary Open Angle Glaucoma: A Randomised Feasibility Study
- ClinicalTrials.gov ID
- NCT02989207
- Acronym / sponsor ID
- PEACE / 160807
- Conditions
- Primary Open Angle Glaucoma
- Keywords
- Glaucoma, Trabeculectomy, Glaucoma drainage implant, Africa and Africa-Caribbean
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 12 Dec 2016 (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 is to perform a randomised feasibility trial preceding a large prospective randomised controlled trial (RCT) comparing three surgical methods - trabeculectomy with Mitomycin C (MMC), primary Baerveldt tube with MMC and Baerveldt tube without MMC - in black African/African Caribbean patients with Primary Open Angle Glaucoma (POAG) living in London.
The UK Office of National Statistics estimated that among the population of England in 2007, approximately 4.3% were of African/African-Caribbean background, while in large cities such as London and Birmingham about 20% of the population is of African/African-Caribbean origin. For eye units in these cities, managing glaucoma in this population is challenging and we need to identify a better alternative to our current standard surgical treatment.
There is now evidence from one RCT which shows better overall outcomes from tube surgery in comparison to trabeculectomy for glaucoma. However, this study did not address black populations specifically and did not address the potential role of MMC in tube surgery.
This feasibility study will enable us to design a fully powered RCT with the aim of determining how best to optimise the surgical treatment of POAG in black populations, by comparing outcomes in three types of glaucoma surgery.
Detailed description
An audit performed at St Thomas's Hospital in 2008 showed that 52 trabeculectomy and 50 Baerveldt tube procedures were done in one year, with 60% of the patients being of 'black' ethnicity. This audit provides the basis for teh recruitment target. Assuming that the majority of the trabeculectomies performed were for POAG then most of these 'black' patients would have been eligible for the trial.
Primary Tube versus Trabeculectomy Study (PTVT) St Thomas' Hospital is the leading recruiting centre for this multinational study. The investigators have recruited over 50 patients in the last 2 years despite the lack of a dedicated research team. The trial retention rate has also been very good with less than 5% loss to follow-up rates.
Patient Feedback and Involvement The proposed research was reviewed in a feedback session in 2012 with 5 black African-Caribbean/African patients with glaucoma attending St Thomas' Hospital. All were very positive about the potential trial and all understood that there is a 'unique' problem for glaucoma surgery in this group of patients. Suggestions for the trial included more emphasis on the importance of treatment for glaucoma, disseminating information about the trial in community centres, and the possibility of expert patients who can act as patient advocates and help with recruitment in the glaucoma clinics and present the study in local community centres.
Feasibility study This protocol is for a randomised feasibility trial which will compare standard treatment (trabeculectomy with MMC) with primary Baerveldt tube surgery with or without MMC in black African/African-Caribbean patients with POAG living in London. The study will look at the feasibility of recruitment for a proposed larger scale RCT and will also help the investigators to refine the methodology for the proposed trial in terms of outcome measures and analysis. It will also help the investigators to recruit a patient user group for input into the conduct and monitoring of the main trial.
Information the study will provide
The investigators are conducting this feasibility study in order to get an estimate of the likely recruitment rate for the main study and to collect information that will help the investigators to refine the outcome measures for the main study and to allow a valid calculation of the sample size needed for a definitive study to answer the primary research question. The investigators will use questionnaires to gather data on patients' quality of life for health economic analysis but it is also our hope that the questionnaires will give the investigators information on the perspectives of patients, including their preferences. This feasibility study will help the investigators to explore how they can gather useful information on the patient perspective.
The feasibility study will also inform their planning for the main trial and data management and help them to develop their community engagement and recruitment strategies, including theri strategy for publicising the trial and enhancing recruitment. In addition, the investigators intend to use the feasibility study to recruit a patient representative group for input into the conduct and monitoring of the proposed main study.
Risks and benefits The potential risks and benefits for patients participating in the feasibility study are similar to those for standard clinical care. All participants will have been identified as in need of glaucoma drainage surgery. Both trabeculectomy (currently as first line treatment) and Baerveldt tube surgery (currently as second line treatment) are in routine use for the treatment of POAG. Evidence on the beneficial effect of MMC is equivocal. First line treatment with Baerveldt tube surgery may be associated with less failure and complications than first line treatment by trabeculectomy but there is as yet no definitive evidence on this question that is specific to the population included in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Trabeculectomy with Mitomycin-C | Active comparator | Procedure: Trabeculectomy, Drug: mitomycin-CThe current standard surgical treatment for glaucoma remains trabeculectomy. |
| Baerveldt tube surgery with Mitomycin C | Active comparator | Device: Baerveldt tube surgery, Drug: mitomycin-CIt consists of a tube, draining aqueous humour to a plate |
| Baerveldt tube surgery without Mitomycin C | Active comparator | Device: Baerveldt tube surgeryIt consists of a tube, draining aqueous humour to a plate |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Able to understand the information sheet and give informed consent.
- Black African Caribbean or African (defined as a person having origins in any of the black racial groups of Africa). The identification of African or African-Caribbean ethnicity will be based on patients' self-reported ethnicity classification in their NHS case notes. In our recent audit, almost 90% of the case notes had data on patients' self-reported ethnicity.
- Age 18 to 85 years, inclusive. Inclusion criteria for study eye
- All of the criteria listed below must be present in the study eye in order for the patient to be eligible for enrolment in the study:
- Glaucoma that is uncontrolled on tolerated medical therapy with IOP ≥18 mmHg and ≤40 mmHg in the study eye.
Key exclusion criteria (21 listed)
- General Exclusion Criteria
- Patients are ineligible to participate in the study where any of the following criteria apply:
- Any inclusion criteria not met.
- Pregnant or nursing women (or planning pregnancy).
- Unwilling or unable to give informed consent, unwilling to accept randomisation, or unable to return for scheduled protocol visits.
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 |
|---|---|---|
| TrabeculectomyAlso: Trabeculectomy with Mitomycin-CThe current standard surgical treatment for glaucoma remains trabeculectomy. Wound healing modulation with antifibrotic agents, like MMC and 5-fluorouracil (5-FU), has been shown to increase the success of glaucoma filtering surgery in high-risk eyes | Procedure or surgery | Trabeculectomy with Mitomycin-C |
| Baerveldt tube surgeryAlso: Baerveldt tube surgery with Mitomycin CAll glaucoma drainage devices consist of a tube which is inserted into the anterior chamber of the eye, draining aqueous humour to a plate which maintains a minimum bleb size and allows the collection of aqueous humour to be absorbed into the surrounding tissue. | Device | Baerveldt tube surgery with Mitomycin C, Baerveldt tube surgery without Mitomycin C |
| mitomycin-CThis is an anti scarring agent whcih is an standard adjunctive treatment in glaucoma surgery | Drug | Baerveldt tube surgery with Mitomycin C, Trabeculectomy with Mitomycin-C |
Primary outcome
Recruitment rate:
Time frame: 6 months
The number of potential participants enrolled over a set time
6 secondary outcomes
Success rate
Time frame: 6 months
Failure rate
Time frame: 6 months
Complication rate
Time frame: 6 months
The number of extra unscheduled clinic visits and unplanned procedures
Time frame: 6 months
Loss to follow-up rate
Time frame: 6 months
Response rates to the self-report
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2016.
- Individual participant dataSharing planned: No
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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, MD principal investigator
Guy's and St Thomas NHS Foundation 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 Trabeculectomy, Baerveldt tube surgery and mitomycin-C in people with Primary Open Angle Glaucoma, 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 7 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 12 Dec 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sheng Lim, MD (+442071884885, shenglim@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate: (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Dec 2016.