Glaucoma Clinical Trial
Official title:
Primary Glaucoma Treatment Trial in Kenya and South Africa - SLT vs. Medication
Multi-centre randomised controlled trial of selective laser trabeculoplasty compared with
prostaglandin analogue therapy as primary treatment for high tension open angle glaucoma.
Participating centres are:
Institute of Ophthalmology, UCL, London, UK McCord Hospital, Durban, South Africa Innovation
Eye Centre, Kisii, Kenya
A debate continues concerning best first-line therapy for African primary open angle
glaucoma. Most African practitioners advocate first line trabeculectomy surgery yet most
frequently practice first line drug therapy because of patient acceptance and other issues.
In the developed world a range of first line therapies including drug, SLT, cyclodiode
ciliary body ablation, trabeculectomy surgery, drainage tube surgery and other drainage
procedures (viscocanalostomy, non-penetrating surgery etc) have been advocated.
There is a paucity of good evidence concerning the relative merits of these approaches in an
African context. The purpose of this study is to compare two approaches to first line therapy
of primary open angle glaucoma in an African population.
Design A two centre randomised prospective trial of SLT vs. prostaglandin analogue first line
therapy for primary open angle glaucoma.
Methods African patients with established or newly diagnosed primary open angle glaucoma or
patients with POAG currently on single drug therapy (excluding prostaglandin analogues) and
elevated IOP are recruited in Innovation Eye Centre in Kisii, Kenya and McCord Hospital,
University of KwaZulu-Natal, Durban, South Africa. While if clinically indicated both eyes
will be treated, one eye per patient to be included in the study.
After informed consent all patients undergo a standardised examination to establish baseline
ocular function and findings. All patients receive counselling in glaucoma, the disease, what
it means and the therapy. The patient is then randomised (randomisation in London, contained
in sealed opaque envelopes) to receive SLT or prostaglandin analogue therapy. Every effort is
made to follow all patients according to a standardised protocol at a minimum of month 3,
month 6 and month 12. All therapeutic failures are followed closely to ascertain further
management plans and subsequent therapeutic compliance. Follow-up is offered beyond 12
months.
Medical therapy Those randomised to medical therapy patients receive free Prostaglandin
analogue in KZN or in Innovation Eye Centre with counselling on drop instillation and
instructions for renewal of their prescription. Prescription renewal is to be free of
charge.. An appointment is given for review in 3 months. Considerable attention is being paid
to estimating compliance including the use of bottle weighing and questionnaires already
developed and used locally.
SLT THERAPY Those randomised to SLT will receive counseling on the effects and management of
SLT.
System: Selecta II (Lumenis) - Frequency doubled Nd: YAG (532nm) Pre-Laser Treatment
- Topical anesthesia (e.g. proxymetacaine hydrochloride)
- Prophylactic application of alpha agonist or equivalent agent (e.g. brimonidine) to
avoid
- Post-op pressure spike
Laser Treatment parameters:
1. Duration 3ns (preset)
2. Spot size 400µ (preset)
3. Number of applications: 100
4. Extent of angle: 360 degree
5. Power (dependent on angle pigmentation)
- If pigmentation is 1 or 2. start at 0.8 mJ and adjust power in 0.1 mJ increments
until visible response (cavitation bubbles - colloquially referred to as "champagne
bubbles")
- If pigment grade is 3 or 4, start at lower energy 0.4 mJ and adjust power in 0.1 mJ
increments until visible response
- When reaching the treatment endpoint (cavitation bubbles), scale down the energy
level by 0.1 mJ and remain on that threshold throughout treatment
- It is recommended to re-evaluate threshold following the treatment of each
quadrant, due to variations in TM pigmentation to reach treatment endpoint
(cavitation bubbles) Post-Laser Treatment
- Patient's IOP follow up - one hour post treatment
- NSAIDS up to 2-3 days post-op, or depending on the level of patient discomfort
- It is not recommended to prescribe steroidal medication as it may potentially
interfere with the SLT mechanism of action.
Follow-up At 3 months Patients will have a structured questionnaire relating to any adverse
effects from the therapeutic interventions. They will receive an examination of visual
function, external ocular structures and intraocular pressure in addition to the optic nerve
head.
Those with unacceptable topical/systemic side effects and those with partial or complete
failure of IOP control (see outcomes) will have secondary therapy commenced in the form of
timolol 0.5% or, if contraindicated, either brimonidine or oral acetazolamide)). The
secondary therapy will either replace or be additive to the primary therapy depending on the
initial response.
At 6 months Patients will have a structured questionnaire relating to any adverse effects
from therapeutic interventions. They will receive and examination of visual function,
external ocular stuctures and intraocular pressure in addition to the optic nerve head.
Those with unacceptable topical/systemic side effects and those with partial or complete
failure of IOP control (see outcomes) will have secondary or tertiary therapy commenced in
the form of timolol 0.5% or, if contraindicated, either brimonidine or oral acetazolamide))
or surgical intervention in the form of a trabeculectomy with cytotoxic.
At 12 months Patients will have a structured questionnaire relating to any adverse effects
from therapeutic interventions. This questionnaire will also include questions relating to
their acceptance of the therapy and view of the therapy. They will receive a detailed
examination of visual function and ocular parameters.
Those with unacceptable topical/systemic side effects and those with partial or complete
failure of IOP control (see outcomes) and those with evidence of glaucoma progression will
have secondary or tertiary therapy commenced in the form of timolol 0.5% or, if
contraindicated, either brimonidine or oral acetazolamide)) or surgical intervention in the
form of a trabeculectomy with cytotoxic.
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