Elsevier

Ophthalmology

Volume 109, Issue 9, September 2002, Pages 1612-1621
Ophthalmology

The European glaucoma prevention study design and baseline description of the participants12 ,

Presented in part at the annual meeting of the Association for Research in Vision and Ophthalmology, Ft. Lauderdale, Florida, May 1999, and May 2000.
https://doi.org/10.1016/S0161-6420(02)01167-3Get rights and content

Abstract

Objectives

The European Glaucoma Prevention Study seeks to evaluate the efficacy of reducing intraocular pressure (IOP), with dorzolamide to prevent or delay patients affected by ocular hypertension from developing primary open-angle glaucoma.

Design

Randomized, double-blinded, controlled clinical trial.

Participants

Patients (age ≥30 years) were enrolled from 18 European centers. The patients fulfilled a series of inclusion criteria including the measurements of IOP (22–29 mmHg), two normal and reliable visual fields (VFs) (on the basis of mean defect and corrected pattern standard deviation/corrected loss of variance of standard 30/II Humphrey or Octopus perimetry), and normal optic disc as determined by the Optic Disc Reading Center (vertical and horizontal cup-to-disc ratios; asymmetry between the two eyes ≤0.4).

Intervention

Patients were randomized to the treatment with dorzolamide or a placebo.

Main outcome measures

End points are VF and/or optic disc changes. A VF change during the follow-up must be confirmed by two further positive tests. Optic disc change is defined by the agreement of two out of three independent observers evaluating optic disc stereo-slides.

Results

One thousand seventy-seven subjects were randomized between January 1, 1997 and May 31, 1999. The mean age was 57.03 ± 10.3 years; 54.41% were women and 99.9% were Caucasian. Mean IOP was 23.6 ± 1.6 mmHg in both eyes. Mean visual acuity was 0.97 ± 0.11 in both eyes; mean refraction was 0.23 ± 1.76 diopters in the right eye and 0.18 ± 1.79 diopters in the left eye. Previous use of medication for ocular hypertension was reported by 38.4% of the patients, systemic hypertension by 28.1%, cardiovascular diseases by 12.9%, and diabetes mellitus by 4.7%. The qualifying VFs were normal and reliable according to protocol criteria.

Conclusions

The mean IOP of the patients enrolled in the European Glaucoma Prevention Study is consistent with the estimated mean IOP (within the range of 22–29 mmHg) found in a large sample of the European population. The European Glaucoma Prevention Study should be able to better address the clinical question of whether pharmacological reduction of IOP (by means of dorzolamide) in ocular hypertension patients at moderate risk for developing primary open-angle glaucoma effectively lowers the incidence of primary open-angle glaucoma.

Section snippets

Subjects and methods

The European Glaucoma Prevention Study is a multicenter randomized, double-blinded, placebo-controlled clinical trial.

Results

The enrollment of the patients began January 1997 and ran through May 1999. A total of 1081 patients were enrolled. However, because of the enrollment of four patients with glaucoma (protocol violators), the overall number of the randomized patients included in the “intention to treat analysis” was reduced to 1077, which included two patients less than 30 years of age (Table 3). The eligibility criteria were met in 146 patients for the right eye only, in 92 for the left eye only, and in 839

Discussion

Presently, the ophthalmic community often attempts to reduce the IOP of patients with OH using topical medical treatment, with the aim of avoiding the progression to POAG. Clear scientific evidence, however, does not support this common clinical procedure. The three major trials published in the past gave rise to controversial and inconclusive results indicating the need for other trials to address such a relevant clinical issue.9, 10, 11 A more recent study, published by Heijl and Bengtsson,32

Acknowledgements

The EGPS Group thanks the Writing Committee responsible for this article: Stefano Miglior, Thierry Zeyen, Norbert Pfeiffer, Jose Cunha-Vaz, Valter Torri, and Ingrid Adamsons.

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    This study is supported by The European Commission (BIOMED II program, contract no.: BMH4-CT-96-1598), and Merck (Whitehouse Station, New Jersey).

    1

    Address correspondence to Stefano Miglior, MD, Universita’ di Milano Bicocca, Ospedale S. Paolo, Via di Rudini’ 8, 20142, Milano, Italy. E-mail: [email protected]

    2

    Reprint requests to Ingrid A. Adamsons, MD, MPH, Merck Research Laboratories, 10 Sentry Parkway, BL1-3, Blue Bell, PA 19422.

    3

    The members of the European Glaucoma Prevention Study (EGPS) Group are listed in the Appendix, and the members of the Writing Committee are listed in the Acknowledgment.

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