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Acta Ophthalmologica 2010

haemorrhages (Leske et al. 2007; As OBF changes are associated to collect a sufficiently large target
Drance et al. 2001), retrobulbar blood with progression of glaucomatous sample.
flow changes (Galassi et al. 2003; Sa- damage (Galassi et al. 2003; Satilmis All patients had been previously
tilmis et al. 2003; Martinez & Sanchez et al. 2003; Martinez & Sanchez 2005; treated with beta-blockers (for
2005; Zeitz et al. 2006) and low perfu- Zeitz et al. 2006), it is conceivable that ‡ 6 months) and showed mean IOP
sion pressure (Leske et al. 2007) have an increase in OBF may protect values ‡ 20 mmHg.
also been found to be significant risk against glaucomatous VF deteriora- The study protocol was approved
factors for glaucomatous VF progres- tion. by the local ethics committee. All
sion. This hypothesis was suggested in a patients were fully informed about the
Although the role of IOP reduction recently published paper by our group details of the study protocol. Written
in preventing VF deterioration has (Martinez & Sanchez 2008a), which informed consent was obtained from
been established in randomized clini- reported that dorzolamide 2% added all subjects at the beginning of the
cal trials (AGIS 2000; Gordon et al. to timolol 0.5%, each given twice study in accordance with the Declara-
2002; Leske et al. 2003, 2007; EGPS daily, may prevent VF deterioration tion of Helsinki.
Group 2007), many patients have over a period of 4 years in individuals All participants were required to
continued to progress despite normali- with primary open-angle glaucoma meet the following inclusion criteria:
zation of their IOP. (POAG). age ‡ 40 years; clinical diagnosis of
Many different drugs used for the The primary aim of this study was POAG; mean diurnal IOP at screen-
treatment of glaucoma have been to identify clinically relevant risk fac- ing ‡ 20 mmHg under treatment with
shown to be effective in lowering tors for progressive VF loss in this beta-blockers (for ‡ 6 months) as
IOP. Among these, topical carbonic group of patients with POAG. Base- monotherapy; mean diurnal IOP at
anhydrase inhibitors (CAIs) have been line and follow-up progression factors baseline ‡ 20 mmHg under treatment
routinely used as concomitant medica- were separately evaluated. The sec- with timolol 0.5% b.i.d. as monother-
tions. ondary aim was to estimate and eval- apy; early VF defect; willingness to
Dorzolamide was the first topical uate the magnitude of the treatment comply with the investigator’s and
CAI with a significant IOP-lowering effect (topical dorzolamide 2% and protocol indications; visual acuity
activity to become available on the brinzolamide 1%, both added to timo- ‡ 0.3 (logarithm of the minimum
market. Clinical studies in humans lol 0.5%) by comparing progression angle resolution [logMAR]), and an
have suggested that dorzolamide 2%, rates in both study groups. equivalent spherical refractive error
used as monotherapy or as adjunctive between + 3.00 D and ) 6.00 D.
therapy to timolol, is well tolerated Materials and Methods Patients were excluded by: any form
and has a good IOP-lowering profile of glaucoma other than POAG; previ-
(Strahlman et al. 1995; Adamsons Study design ous treatment with argon laser trabe-
et al. 1998; Boyle et al. 1998; Cli- culoplasty and ⁄ or ocular filtering
neschmidt et al. 1998; Sugrue 2000; A randomized, evaluator-masked, par- surgery; diabetes; history of progres-
EGPS Group 2005; Ozturk et al. allel group design was used. Patients sive retinal or optic nerve disease of
2007). Previous evidence has shown received either dorzolamide 2% or any cause; asthma or any other
the ocular haemodynamic effects of brinzolamide 1%, each added to timo- obstructive pulmonary disease, and
topically applied dorzolamide (Marti- lol maleate 0.5%, b.i.d. (administered pregnancy or lactation.
nez et al. 1999; Avunduk et al. 2001; separately rather than as a fixed-dose Although subjects with systemic
Galassi et al. 2002; Januleviciene ¨ et al. combination) for 5 years. hypertension or cardiovascular disease
2004; Fuchsja ¨ ger-Mayrl et al. 2005; Unmasked staff were responsible were not excluded, patients receiving
Martinez & Sanchez 2006, 2007, for dispensing study medication, systemic medications affecting IOP or
2008a), although not all studies have whereas masked staff performed all systemic blood pressure were ineligible
reported a positive outcome (Grun- study-related examinations. unless medication dosages had
wald et al. 1997; Pillunat et al. 1999; Patients and unmasked staff were remained stable for ‡ 6 months prior
Bergstrand et al. 2002). Brinzolamide, instructed not to reveal study drug to the screening visit.
another topically active CAI, became assignments to the masked evaluator.
available in the USA in 1998 and in Definitions
many European countries in 1999. Patient recruitment
Different authors have assessed the Glaucoma was defined as either a VF
efficacy and safety of brinzolamide The study was conducted on consecu- defect or as glaucomatous changes in
in clinical studies and have sug- tive referred or recruited patients who the optic nerve head.
gested that the compound has good met inclusion and exclusion criteria, For glaucoma diagnosis, VF exam-
IOP-lowering activity (Silver 1998; seen at the outpatient clinic of the inations were performed using the
March & Ochsner 2000; Shall et al. Ophthalmology Department (Public 24-2 full-threshold strategy on the
2000). Foundation Barbanza Hospital, asso- Humphrey VF analyser. Glaucoma-
Relatively few studies have evalu- ciated with the Galician Institute of tous VF defects were defined as
ated the effect of topical brinzolamide Ophthalmology [Instituto Galego de follows: a minimum of one location in
on ocular blood flow (OBF) in Oftalmoloxia], Spain) from January the paracentral or nasal step regions
glaucoma patients (Kaup et al. 2004; 1999 to December 2001. A 3-year corresponding to sectors 1 or 2, or to
Siesky et al. 2008). recruitment period was used in order the inferior 3 location in sector 3 of

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