Results of the European Glaucoma Prevention Study

doi:10.1016/j.ophtha.2004.11.030

Ophthalmology

Volume 112, Issue 3, March 2005, Pages 366-375

https://doi.org/10.1016/j.ophtha.2004.11.030 Get rights and content

Objective

The European Glaucoma Prevention Study (EGPS) seeks to evaluate the efficacy of reduction of intraocular pressure (IOP) by dorzolamide in preventing or delaying primary open-angle glaucoma (POAG) in patients affected by ocular hypertension (OHT).

Design

Randomized, double-masked, controlled clinical trial.

Participants

One thousand eighty-one patients (age, ≥30 years) were enrolled by 18 European centers. The patients fulfilled a series of inclusion criteria, including: IOP 22 to 29 mmHg; 2 normal and reliable visual fields (on the basis of mean deviation and corrected pattern standard deviation or corrected loss variance of standard 30/II Humphrey or Octopus perimetry); normal optic disc as determined by the Optic Disc Reading Center.

Intervention

Patients were randomized to treatment with dorzolamide or placebo (the vehicle of dorzolamide).

Main outcome measures

Efficacy end points were visual field, optic disc changes, or both. A visual field change during follow-up had to be confirmed by 2 further positive tests. Optic disc change was defined on the basis of the agreement of 2 of 3 independent observers evaluating optic disc stereo slides. The safety end point was an IOP of more than 35 mmHg on 2 consecutive examinations.

Results

During the course of the study, the mean percent reduction in IOP in the dorzolamide group was 15% after 6 months and 22% after 5 years. Mean IOP declined by 9% after 6 months and by 19% after 5 years in the placebo group. At 60 months, the cumulative probability of converting to an efficacy end point was 13.4% in the dorzolamide group and 14.1% in the placebo group (hazard ratio, 0.86; 95% confidence interval [CI], 0.58–1.26; P = 0.45). The cumulative probability of developing an efficacy or a safety end point was 13.7% in the dorzolamide group and 16.4% in the placebo group (hazard ratio, 0.73; 95% CI, 0.51–1.06; P = 0.1).

Conclusions

Dorzolamide reduced IOP by 15% to 22% throughout the 5 years of the trial. However, the EGPS failed to detect a statistically significant difference between medical therapy and placebo in reducing the incidence of POAG among a large population of OHT patients at moderate risk for developing POAG, because placebo also significantly and consistently lowered IOP.

Section snippets

Patients and methods

The EGPS was a multicenter, randomized, double-masked, placebo-controlled clinical trial. The design and methods of the EGPS were described previously²⁰ and are summarized as follows.

Results

The enrollment of the patients lasted from January 1997 through May 1999. A total of 1081 patients were enrolled. However, because of the enrollment of 4 patients with glaucoma (i.e., major protocol violators), the overall number of the randomized patients included in the intention-to-treat analysis was reduced to 1077 (including 2 patients younger than 30 years).

The details concerning the baseline description of the participants were provided in the previously published article.²⁰ In addition,

Discussion

At the time the EGPS was designed, there was no clear clinical evidence concerning the relationship between pressure reduction and conversion to POAG.²⁷ Management of OHT patients mainly was based on clinical experience or the results of conflicting clinical studies. The recently published results of the OHTS have shown that it is possible to prevent or delay the development of POAG in OHT patients by achieving an 18% net IOP reduction from baseline maintained for at least 5 years.⁹

The EGPS

Acknowledgments

The EGPS Group acknowledges the members of the Writing Committee: Stefano Miglior, Thierry Zeyen, Norbert Pfeiffer, Jose Cunha-Vaz, Valter Torri, and Ingrid Adamsons.

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: Manuscript no. 240378.

: Supported by The European Commission, Brussels, Belgium (BIOMED II program, contract no.: BMH4-CT-96-1598), and Merck & Co., Inc., Whitehouse Station, New Jersey.

: [email protected]

¹: See “Appendix” for a list of the group's members, and “Acknowledgments” for writing committee identification.

View full text

Original articleResults of the European Glaucoma Prevention Study

Objective

Design

Participants

Intervention

Main outcome measures

Results

Conclusions

Section snippets

Patients and methods

Results

Discussion

Acknowledgments

Am J Ophthalmol

Ophthalmology

Ophthalmology

Ophthalmology

Clin Ther

Prog Retin Eye Res

Surv Ophthalmol

Ophthalmology

Control Clin Trials

Am J Ophthalmol

Am J Ophthalmol

Ophthalmology

Ophthalmology

Preferred Practice Pattern. Primary Open-Angle Glaucoma

Relationship between intraocular pressure and primary open angle glaucoma among white and black AmericansThe Baltimore Eye Survey

Arch Ophthalmol

Hypertension, perfusion pressure, and primary open angle glaucomaA population-based assessment

Arch Ophthalmol

Risk factors for open-angle glaucomaThe Barbados Eye Study

Arch Ophthalmol

Family history and risk of primary open angle glaucomaThe Baltimore Eye Survey

Arch Ophthalmol

Elevated intraocular pressure and pseudoexfoliation of the lens capsule as risk factors for chronic open-angle glaucomaA population-based five-year follow-up study

Acta Ophthalmol

Original article
Results of the European Glaucoma Prevention Study