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The Ocular Hypertension Treatment Study: a randomized trial determines that topical ocular hypotensive medication delays or prevents the onset of primary open-angle glaucoma.
Arch Ophthalmol 2002; 120(6):701-13; discussion 829-30AO

Abstract

BACKGROUND

Primary open-angle glaucoma (POAG) is one of the leading causes of blindness in the United States and worldwide. Three to 6 million people in the United States are at increased risk for developing POAG because of elevated intraocular pressure (IOP), or ocular hypertension. There is no consensus on the efficacy of medical treatment in delaying or preventing the onset of POAG in individuals with elevated IOP. Therefore, we designed a randomized clinical trial, the Ocular Hypertension Treatment Study.

OBJECTIVE

To determine the safety and efficacy of topical ocular hypotensive medication in delaying or preventing the onset of POAG.

METHODS

A total of 1636 participants with no evidence of glaucomatous damage, aged 40 to 80 years, and with an IOP between 24 mm Hg and 32 mm Hg in one eye and between 21 mm Hg and 32 mm Hg in the other eye were randomized to either observation or treatment with commercially available topical ocular hypotensive medication. The goal in the medication group was to reduce the IOP by 20% or more and to reach an IOP of 24 mm Hg or less.

MAIN OUTCOME MEASURES

The primary outcome was the development of reproducible visual field abnormality or reproducible optic disc deterioration attributed to POAG. Abnormalities were determined by masked certified readers at the reading centers, and attribution to POAG was decided by the masked Endpoint Committee.

RESULTS

During the course of the study, the mean +/- SD reduction in IOP in the medication group was 22.5% +/- 9.9%. The IOP declined by 4.0% +/- 11.6% in the observation group. At 60 months, the cumulative probability of developing POAG was 4.4% in the medication group and 9.5% in the observation group (hazard ratio, 0.40; 95% confidence interval, 0.27-0.59; P<.0001). There was little evidence of increased systemic or ocular risk associated with ocular hypotensive medication.

CONCLUSIONS

Topical ocular hypotensive medication was effective in delaying or preventing the onset of POAG in individuals with elevated IOP. Although this does not imply that all patients with borderline or elevated IOP should receive medication, clinicians should consider initiating treatment for individuals with ocular hypertension who are at moderate or high risk for developing POAG.

Authors+Show Affiliations

Department of Ophthalmology and Visual Sciences, Washington University School of Medicine, St Louis, MO 63110, USA.No affiliation info availableNo 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
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

12049574

Citation

Kass, Michael A., et al. "The Ocular Hypertension Treatment Study: a Randomized Trial Determines That Topical Ocular Hypotensive Medication Delays or Prevents the Onset of Primary Open-angle Glaucoma." Archives of Ophthalmology (Chicago, Ill. : 1960), vol. 120, no. 6, 2002, pp. 701-13; discussion 829-30.
Kass MA, Heuer DK, Higginbotham EJ, et al. The Ocular Hypertension Treatment Study: a randomized trial determines that topical ocular hypotensive medication delays or prevents the onset of primary open-angle glaucoma. Arch Ophthalmol. 2002;120(6):701-13; discussion 829-30.
Kass, M. A., Heuer, D. K., Higginbotham, E. J., Johnson, C. A., Keltner, J. L., Miller, J. P., ... Gordon, M. O. (2002). The Ocular Hypertension Treatment Study: a randomized trial determines that topical ocular hypotensive medication delays or prevents the onset of primary open-angle glaucoma. Archives of Ophthalmology (Chicago, Ill. : 1960), 120(6), pp. 701-13; discussion 829-30.
Kass MA, et al. The Ocular Hypertension Treatment Study: a Randomized Trial Determines That Topical Ocular Hypotensive Medication Delays or Prevents the Onset of Primary Open-angle Glaucoma. Arch Ophthalmol. 2002;120(6):701-13; discussion 829-30. PubMed PMID: 12049574.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The Ocular Hypertension Treatment Study: a randomized trial determines that topical ocular hypotensive medication delays or prevents the onset of primary open-angle glaucoma. AU - Kass,Michael A, AU - Heuer,Dale K, AU - Higginbotham,Eve J, AU - Johnson,Chris A, AU - Keltner,John L, AU - Miller,J Philip, AU - Parrish,Richard K,2nd AU - Wilson,M Roy, AU - Gordon,Mae O, PY - 2002/6/7/pubmed PY - 2002/6/18/medline PY - 2002/6/7/entrez SP - 701-13; discussion 829-30 JF - Archives of ophthalmology (Chicago, Ill. : 1960) JO - Arch. Ophthalmol. VL - 120 IS - 6 N2 - BACKGROUND: Primary open-angle glaucoma (POAG) is one of the leading causes of blindness in the United States and worldwide. Three to 6 million people in the United States are at increased risk for developing POAG because of elevated intraocular pressure (IOP), or ocular hypertension. There is no consensus on the efficacy of medical treatment in delaying or preventing the onset of POAG in individuals with elevated IOP. Therefore, we designed a randomized clinical trial, the Ocular Hypertension Treatment Study. OBJECTIVE: To determine the safety and efficacy of topical ocular hypotensive medication in delaying or preventing the onset of POAG. METHODS: A total of 1636 participants with no evidence of glaucomatous damage, aged 40 to 80 years, and with an IOP between 24 mm Hg and 32 mm Hg in one eye and between 21 mm Hg and 32 mm Hg in the other eye were randomized to either observation or treatment with commercially available topical ocular hypotensive medication. The goal in the medication group was to reduce the IOP by 20% or more and to reach an IOP of 24 mm Hg or less. MAIN OUTCOME MEASURES: The primary outcome was the development of reproducible visual field abnormality or reproducible optic disc deterioration attributed to POAG. Abnormalities were determined by masked certified readers at the reading centers, and attribution to POAG was decided by the masked Endpoint Committee. RESULTS: During the course of the study, the mean +/- SD reduction in IOP in the medication group was 22.5% +/- 9.9%. The IOP declined by 4.0% +/- 11.6% in the observation group. At 60 months, the cumulative probability of developing POAG was 4.4% in the medication group and 9.5% in the observation group (hazard ratio, 0.40; 95% confidence interval, 0.27-0.59; P<.0001). There was little evidence of increased systemic or ocular risk associated with ocular hypotensive medication. CONCLUSIONS: Topical ocular hypotensive medication was effective in delaying or preventing the onset of POAG in individuals with elevated IOP. Although this does not imply that all patients with borderline or elevated IOP should receive medication, clinicians should consider initiating treatment for individuals with ocular hypertension who are at moderate or high risk for developing POAG. SN - 0003-9950 UR - https://www.unboundmedicine.com/medline/citation/12049574/The_Ocular_Hypertension_Treatment_Study:_a_randomized_trial_determines_that_topical_ocular_hypotensive_medication_delays_or_prevents_the_onset_of_primary_open_angle_glaucoma_ L2 - https://jamanetwork.com/journals/jamaophthalmology/fullarticle/vol/120/pg/701 DB - PRIME DP - Unbound Medicine ER -