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

• Register: ClinicalTrials.gov
• Last refreshed on: 9 January 2017
• Main ID: NCT02989207
• Date of registration: 02/12/2016
• Prospective Registration: No
• Primary sponsor: Guy's and St Thomas' NHS Foundation Trust
• Public title: Surgical Approaches in Treating Uncontrolled Glaucoma in Black African and African-Caribbeans PEACE
• Scientific title: Comparing Surgical Approaches to Treat Black African and Africa-Caribbean Patients With Uncontrolled Primary Open Angle Glaucoma: A Randomised Feasibility Study
• Date of first enrolment: August 2016
• Target sample size: 60
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02989207
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

United Kingdom

Contacts

• Name: K Sheng Lim, MD

• Name: K Sheng Lim, MD
• Affiliation: Guy's and St Thomas NHS Foundation Trust

• Name: Sheng Lim, MD

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Primary Open Angle Glaucoma

Intervention(s)

Device: Baerveldt tube surgery

Drug: mitomycin-C

Procedure: Trabeculectomy

Primary Outcome(s)

Recruitment rate: [Time Frame: 6 months]

Secondary Outcome(s)

Success rate [Time Frame: 6 months]

The number of extra unscheduled clinic visits and unplanned procedures [Time Frame: 6 months]

Response rates to the self-report [Time Frame: 6 months]

Failure rate [Time Frame: 6 months]

Loss to follow-up rate [Time Frame: 6 months]

Complication rate [Time Frame: 6 months]

Secondary ID(s)

160807

15/LO/1810

Source(s) of Monetary Support

Please refer to primary and secondary sponsors