Surgical Approaches in Treating Uncontrolled Glaucoma in Black African and African-Caribbeans

NCT02989207 | Unknown DMC

• 2 other identifiers: 16080715/LO/1810
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Open Angle Glaucoma

Keywords

Glaucoma; Trabeculectomy; Glaucoma drainage implant; Africa and Africa-Caribbean

Outcome Measures

Primary Outcomes (1)

• Recruitment rate:

  The number of potential participants enrolled over a set time

  6 months

Secondary Outcomes (6)

• Success rate

  6 months

• Failure rate

  6 months

• Complication rate

  6 months

• The number of extra unscheduled clinic visits and unplanned procedures

  6 months

• Loss to follow-up rate

  6 months

Study Arms (3)

Trabeculectomy with Mitomycin-C

ACTIVE COMPARATOR

The current standard surgical treatment for glaucoma remains trabeculectomy.

Procedure: Trabeculectomy; Drug: mitomycin-C

Baerveldt tube surgery with Mitomycin C

ACTIVE COMPARATOR

It consists of a tube, draining aqueous humour to a plate

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

Device: Baerveldt tube surgery

Interventions

Trabeculectomy PROCEDURE

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

Also known as: Trabeculectomy with Mitomycin-C

Trabeculectomy with Mitomycin-C

Baerveldt tube surgery DEVICE

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.

Also known as: Baerveldt tube surgery with Mitomycin C

Baerveldt tube surgery with Mitomycin C; Baerveldt tube surgery without Mitomycin C

mitomycin-C DRUG

This is an anti scarring agent whcih is an standard adjunctive treatment in glaucoma surgery

Baerveldt tube surgery with Mitomycin C; Trabeculectomy with Mitomycin-C

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• Patients are ineligible to participate in the study where any of the following criteria apply:
• 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.
• 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.

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

Study Sites (1)

St Thomas Hospital

London, SE1 7EH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-Angle; Glaucoma

Interventions

Trabeculectomy; Mitomycin

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Filtering Surgery; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• K Sheng Lim, MD

  Guy's and St Thomas NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheng Lim, MD

CONTACT

+442071884885; shenglim@gmail.com

Stephanie Jones

CONTACT

+442071884885; stephanie.jones@gstt.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2016
• First Posted: December 12, 2016
• Study Start: August 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 12, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)