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Results of the European Glaucoma Prevention Study.
Ophthalmology 2005; 112(3):366-75O

Abstract

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, > or =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.

Authors

No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15745761

Citation

Miglior, Stefano, et al. "Results of the European Glaucoma Prevention Study." Ophthalmology, vol. 112, no. 3, 2005, pp. 366-75.
Miglior S, Zeyen T, Pfeiffer N, et al. Results of the European Glaucoma Prevention Study. Ophthalmology. 2005;112(3):366-75.
Miglior, S., Zeyen, T., Pfeiffer, N., Cunha-Vaz, J., Torri, V., & Adamsons, I. (2005). Results of the European Glaucoma Prevention Study. Ophthalmology, 112(3), pp. 366-75.
Miglior S, et al. Results of the European Glaucoma Prevention Study. Ophthalmology. 2005;112(3):366-75. PubMed PMID: 15745761.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Results of the European Glaucoma Prevention Study. AU - Miglior,Stefano, AU - Zeyen,Thierry, AU - Pfeiffer,Norbert, AU - Cunha-Vaz,Jose, AU - Torri,Valter, AU - Adamsons,Ingrid, AU - ,, PY - 2004/05/18/received PY - 2004/11/15/accepted PY - 2005/3/5/pubmed PY - 2005/3/16/medline PY - 2005/3/5/entrez SP - 366 EP - 75 JF - Ophthalmology JO - Ophthalmology VL - 112 IS - 3 N2 - 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, > or =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. SN - 1549-4713 UR - https://www.unboundmedicine.com/medline/citation/15745761/Results_of_the_European_Glaucoma_Prevention_Study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0161-6420(04)01786-5 DB - PRIME DP - Unbound Medicine ER -