Document Detail

Enhanced disruption of the blood-aqueous barrier and the incidence of angiographic cystoid macular edema by topical timolol and its preservative in early postoperative pseudophakia.
MedLine Citation:
PMID:  11231772     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: To investigate the effects of timolol maleate with preservative and its preserved (PV) and nonpreserved vehicles (NPV) (benzalkonium chloride) on the blood-aqueous barrier and angiographic cystoid macular edema (CME) in early postoperative pseudophakia. PATIENTS AND METHODS: Patients with ocular hypertension, normal tension glaucoma, and primary open-angle glaucoma who underwent surgery for cataracts. The study included a double-masked trial for timolol, PV, and NPV and a single-masked trial on the effect of diclofenac sodium and fluorometholone acetate on all three. The patients were divided into 6 groups, each of which were simultaneously administered the following different combinations of compounds: timolol and diclofenac (group A), timolol and fluorometholone (group B), PV and diclofenac (group C), PV and fluorometholone (group D), NPV and diclofenac (group E), and NPV and fluorometholone (group F). The 6 groups were then compared using a laser flare cell meter to determine the degree of disruption of the blood-aqueous barrier and fluorescein angiography to investigate angiographic CME. The differences in mean daily fluctuations in intraocular pressure were compared on the preoperative baseline day and for 5 weeks postoperatively. Twice daily administration of 0.5% timolol maleate or the vehicles was started 2 days before surgery, and continued until 5 weeks after surgery. Diclofenac or fluorometholone drops were instilled in the eyes 4 times preoperatively, on the day of surgery, and 3 times daily for 5 weeks postoperatively. RESULTS: The flare amount was higher on the third and seventh days in group B than in group D, but was the same after the seventh day. The incidence of angiographic CME was the same between both groups. These 2 factors were significantly lower in group F. These 2 factors were also significantly lower in the 3 groups that received diclofenac instead of fluorometholone, with no difference among these groups. The intraocular pressure decline was significant in groups that received timolol compared with groups that received PV or NPV. CONCLUSIONS: Timolol and its preservative, benzalkonium chloride, cause disruption of the blood-aqueous barrier in early postoperative pseudophakia and increased incidence of angiographic CME. The concurrent administration of nonsteroidal anti-inflammatory drug such as diclofenac prevents these adverse effects without interfering with the drop in intraocular pressure caused by timolol. The addition of benzalkonium chloride to timolol contributes considerably to these adverse effects. CLINICAL RELEVANCE: The present results suggest the cause of similar complications produced by other antiglaucoma eyedrops containing similar preservatives.
K Miyake; I Ota; N Ibaraki; J Akura; S Ichihashi; Y Shibuya; K Maekubo; S Miyake
Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  Archives of ophthalmology     Volume:  119     ISSN:  0003-9950     ISO Abbreviation:  Arch. Ophthalmol.     Publication Date:  2001 Mar 
Date Detail:
Created Date:  2001-03-20     Completed Date:  2001-04-05     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  7706534     Medline TA:  Arch Ophthalmol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  387-94     Citation Subset:  AIM; IM    
Shohzankai Medical Foundation, Miyake Eye Hospital, 1070-Kami 5, Higashiozone-cho, Kita-ku, Nagoya, 462-0823, Japan.
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MeSH Terms
Administration, Topical
Adrenergic beta-Antagonists / administration & dosage,  adverse effects
Anterior Eye Segment / blood supply*
Anti-Inflammatory Agents / therapeutic use
Anti-Inflammatory Agents, Non-Steroidal / therapeutic use
Benzalkonium Compounds / administration & dosage,  adverse effects
Blood-Aqueous Barrier / drug effects*
Capillary Permeability / drug effects*
Diclofenac / therapeutic use
Double-Blind Method
Fluorescein Angiography*
Fluorometholone / therapeutic use
Glaucoma, Open-Angle / drug therapy
Intraocular Pressure / drug effects
Macular Edema / chemically induced*,  prevention & control
Ocular Hypertension / drug therapy
Preservatives, Pharmaceutical / administration & dosage,  adverse effects*
Pseudophakia / complications*,  drug therapy
Single-Blind Method
Timolol / administration & dosage,  adverse effects*
Reg. No./Substance:
0/Adrenergic beta-Antagonists; 0/Anti-Inflammatory Agents; 0/Anti-Inflammatory Agents, Non-Steroidal; 0/Benzalkonium Compounds; 0/Preservatives, Pharmaceutical; 15307-86-5/Diclofenac; 26839-75-8/Timolol; 426-13-1/Fluorometholone

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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