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Interim clinical outcomes in the Collaborative Initial Glaucoma Treatment Study comparing initial treatment randomized to medications or surgery.

Abstract

PURPOSE

To report interim outcome data, using all available follow-up through 5 years after treatment initiation, in the Collaborative Initial Glaucoma Treatment Study (CIGTS).

DESIGN

Randomized clinical trial.

PARTICIPANTS

Six hundred seven newly diagnosed glaucoma patients.

METHODS

In a randomized clinical trial, 607 patients with newly diagnosed open-angle glaucoma were initially treated with either medication or trabeculectomy (with or without 5-fluorouracil). After treatment onset and early follow-up, patients were evaluated clinically at 6-month intervals. In addition, quality of life telephone interviews were conducted at similar frequency to the clinical visits. Patients in both arms of CIGTS were treated aggressively in an effort to reduce intraocular pressure (IOP) to a level at or below a predetermined target pressure specific for each individual eye. Visual field (VF) scores were analyzed by time-specific comparisons and by repeated measures models.

MAIN OUTCOME MEASURES

VF loss was the primary outcome variable in CIGTS. Secondary outcomes of visual acuity (VA), IOP, and cataract were also studied.

RESULTS

On the basis of completed follow-up through 4 years and partially completed through 5 years, VF loss did not differ significantly by initial treatment. Over the entire period of follow-up, surgical patients had a greater risk of substantial VA loss compared with medical patients. However, by 4 years after treatment, the average VA in the two groups was about equal. Over the course of follow-up, IOP in the medicine group has averaged 17 to 18 mmHg, whereas that in the surgery group averaged 14 to 15 mmHg. The rate of cataract requiring removal was greater in the surgically treated group.

CONCLUSIONS

Both initial medical or initial surgical therapy result in about the same VF outcome after up to 5 years of follow-up. VA loss was greater in the surgery group, but the differences between groups seem to be converging as follow-up continues. When aggressive treatment aimed at substantial reduction in IOP from baseline is used, loss of VF can be seen to be minimal in general. Because 4 to 5 years of follow-up in a chronic disease is not adequate to draw treatment conclusions, these interim CIGTS outcomes do not support altering current treatment approaches to open-angle glaucoma.

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  • Authors+Show Affiliations

    ,

    Department of Ophthalmology and Visual Sciences, Kellogg Eye Center, The University of Michigan, Ann Arbor, Michigan 48105, USA.

    , , , , , ,

    Source

    Ophthalmology 108:11 2001 Nov pg 1943-53

    MeSH

    Adrenergic beta-Antagonists
    Adult
    Aged
    Cataract
    Female
    Fluorouracil
    Follow-Up Studies
    Glaucoma, Open-Angle
    Humans
    Intraocular Pressure
    Intraoperative Complications
    Male
    Middle Aged
    Ophthalmic Solutions
    Prospective Studies
    Quality of Life
    Trabeculectomy
    Treatment Outcome
    Visual Acuity
    Visual Fields

    Pub Type(s)

    Clinical Trial
    Comparative Study
    Journal Article
    Multicenter Study
    Randomized Controlled Trial
    Research Support, U.S. Gov't, P.H.S.

    Language

    eng

    PubMed ID

    11713061

    Citation

    Lichter, P R., et al. "Interim Clinical Outcomes in the Collaborative Initial Glaucoma Treatment Study Comparing Initial Treatment Randomized to Medications or Surgery." Ophthalmology, vol. 108, no. 11, 2001, pp. 1943-53.
    Lichter PR, Musch DC, Gillespie BW, et al. Interim clinical outcomes in the Collaborative Initial Glaucoma Treatment Study comparing initial treatment randomized to medications or surgery. Ophthalmology. 2001;108(11):1943-53.
    Lichter, P. R., Musch, D. C., Gillespie, B. W., Guire, K. E., Janz, N. K., Wren, P. A., & Mills, R. P. (2001). Interim clinical outcomes in the Collaborative Initial Glaucoma Treatment Study comparing initial treatment randomized to medications or surgery. Ophthalmology, 108(11), pp. 1943-53.
    Lichter PR, et al. Interim Clinical Outcomes in the Collaborative Initial Glaucoma Treatment Study Comparing Initial Treatment Randomized to Medications or Surgery. Ophthalmology. 2001;108(11):1943-53. PubMed PMID: 11713061.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Interim clinical outcomes in the Collaborative Initial Glaucoma Treatment Study comparing initial treatment randomized to medications or surgery. AU - Lichter,P R, AU - Musch,D C, AU - Gillespie,B W, AU - Guire,K E, AU - Janz,N K, AU - Wren,P A, AU - Mills,R P, AU - ,, PY - 2001/11/20/pubmed PY - 2002/1/5/medline PY - 2001/11/20/entrez SP - 1943 EP - 53 JF - Ophthalmology JO - Ophthalmology VL - 108 IS - 11 N2 - PURPOSE: To report interim outcome data, using all available follow-up through 5 years after treatment initiation, in the Collaborative Initial Glaucoma Treatment Study (CIGTS). DESIGN: Randomized clinical trial. PARTICIPANTS: Six hundred seven newly diagnosed glaucoma patients. METHODS: In a randomized clinical trial, 607 patients with newly diagnosed open-angle glaucoma were initially treated with either medication or trabeculectomy (with or without 5-fluorouracil). After treatment onset and early follow-up, patients were evaluated clinically at 6-month intervals. In addition, quality of life telephone interviews were conducted at similar frequency to the clinical visits. Patients in both arms of CIGTS were treated aggressively in an effort to reduce intraocular pressure (IOP) to a level at or below a predetermined target pressure specific for each individual eye. Visual field (VF) scores were analyzed by time-specific comparisons and by repeated measures models. MAIN OUTCOME MEASURES: VF loss was the primary outcome variable in CIGTS. Secondary outcomes of visual acuity (VA), IOP, and cataract were also studied. RESULTS: On the basis of completed follow-up through 4 years and partially completed through 5 years, VF loss did not differ significantly by initial treatment. Over the entire period of follow-up, surgical patients had a greater risk of substantial VA loss compared with medical patients. However, by 4 years after treatment, the average VA in the two groups was about equal. Over the course of follow-up, IOP in the medicine group has averaged 17 to 18 mmHg, whereas that in the surgery group averaged 14 to 15 mmHg. The rate of cataract requiring removal was greater in the surgically treated group. CONCLUSIONS: Both initial medical or initial surgical therapy result in about the same VF outcome after up to 5 years of follow-up. VA loss was greater in the surgery group, but the differences between groups seem to be converging as follow-up continues. When aggressive treatment aimed at substantial reduction in IOP from baseline is used, loss of VF can be seen to be minimal in general. Because 4 to 5 years of follow-up in a chronic disease is not adequate to draw treatment conclusions, these interim CIGTS outcomes do not support altering current treatment approaches to open-angle glaucoma. SN - 0161-6420 UR - https://www.unboundmedicine.com/medline/citation/11713061/full_citation L2 - https://linkinghub.elsevier.com/retrieve/pii/S0161-6420(01)00873-9 DB - PRIME DP - Unbound Medicine ER -