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Surgical Approaches in Treating Uncontrolled Glaucoma in Black African and African-Caribbeans (PEACE)

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ClinicalTrials.gov Identifier: NCT02989207
Recruitment Status : Unknown
Verified December 2016 by Guy's and St Thomas' NHS Foundation Trust.
Recruitment status was:  Recruiting
First Posted : December 12, 2016
Last Update Posted : December 12, 2016
Sponsor:
Information provided by (Responsible Party):
Guy's and St Thomas' NHS Foundation Trust

Brief 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 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.


Condition or disease Intervention/treatment Phase
Primary Open Angle Glaucoma Procedure: Trabeculectomy Device: Baerveldt tube surgery Drug: mitomycin-C Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparing Surgical Approaches to Treat Black African and Africa-Caribbean Patients With Uncontrolled Primary Open Angle Glaucoma: A Randomised Feasibility Study
Study Start Date : August 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017


Arm Intervention/treatment
Active Comparator: Trabeculectomy with Mitomycin-C
The current standard surgical treatment for glaucoma remains trabeculectomy.
Procedure: Trabeculectomy
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
Other Name: Trabeculectomy with Mitomycin-C

Drug: mitomycin-C
This is an anti scarring agent whcih is an standard adjunctive treatment in glaucoma surgery

Active Comparator: Baerveldt tube surgery with Mitomycin C
It consists of a tube, draining aqueous humour to a plate
Device: Baerveldt tube surgery
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.
Other Name: Baerveldt tube surgery with Mitomycin C

Drug: mitomycin-C
This is an anti scarring agent whcih is an standard adjunctive treatment in glaucoma surgery

Active Comparator: Baerveldt tube surgery without Mitomycin C
It consists of a tube, draining aqueous humour to a plate
Device: Baerveldt tube surgery
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.
Other Name: Baerveldt tube surgery with Mitomycin C




Primary Outcome Measures :
  1. Recruitment rate: [ Time Frame: 6 months ]
    The number of potential participants enrolled over a set time


Secondary Outcome Measures :
  1. Success rate [ Time Frame: 6 months ]
    Eyes that have not failed and are not on supplemental medical therapy are considered complete successes

  2. Failure rate [ Time Frame: 6 months ]
    • 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

  3. Complication rate [ Time Frame: 6 months ]
  4. The number of extra unscheduled clinic visits and unplanned procedures [ Time Frame: 6 months ]
  5. Loss to follow-up rate [ Time Frame: 6 months ]
  6. Response rates to the self-report [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02989207


Contacts
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Contact: Sheng Lim, MD +442071884885 shenglim@gmail.com
Contact: Stephanie Jones +442071884885 stephanie.jones@gstt.nhs.uk

Locations
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United Kingdom
St Thomas Hospital Recruiting
London, United Kingdom, SE1 7EH
Contact: K Sheng Lim, MD    +442071884885    shenglim@gmail.com   
Contact: Stephanie Jones, BSc    +442071884885    stephanie.jones@gsst.nhs.uk   
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
Investigators
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Principal Investigator: K Sheng Lim, MD Guy's and St Thomas NHS Foundation Trust

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Responsible Party: Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02989207     History of Changes
Other Study ID Numbers: 160807
15/LO/1810 ( Other Identifier: Health Reseach Authority )
First Posted: December 12, 2016    Key Record Dates
Last Update Posted: December 12, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Guy's and St Thomas' NHS Foundation Trust:
Glaucoma
Trabeculectomy
Glaucoma drainage implant
Africa and Africa-Caribbean

Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Mitomycins
Mitomycin
Antibiotics, Antineoplastic
Antineoplastic Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors