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Friday, July 04, 2008
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 Herpetic Eye Disease
Study
- To evaluate
the efficacy of topical corticosteroids in treating herpes
simplex stromal keratitis in conjunction with topical trifluridine.
- To evaluate
the efficacy of oral acyclovir in treating herpes simplex
stromal keratitis in patients receiving concomitant topical
corticosteroids and trifluridine.
- To evaluate
the efficacy of oral acyclovir in treating herpes simplex
iridocyclitis in conjunction with treatment with topical
corticosteroids and trifluridine.
Herpes simplex
keratitis is a leading cause of corneal opacification in the
United States, other industrialized countries, and developing
nations throughout the world. An estimated 450,000 people
in the United States can develop recurrent episodes of the
disease and about 46,000 episodes of HSV eye infection every
year. Herpetic eye disease is the most common infectious cause
of corneal blindness in this country.
Despite the availability of antiviral agents that are effective
in treating herpes simplex epithelial keratitis, inflammation
in the corneal connective tissue and iris that can lead to
corneal scarring and visual impairment develops in many patients.
Prior to the HEDS-I trials, the role of topical corticosteroids
in the management of HSV stromal keratitis was uncertain;
some animal and human studies suggested there was a benefit
to treatment whereas others suggested harm. The value of adding
an oral antiviral agent to treatment with topical corticosteroids
and topical antivirals also was unknown.
The HEDS-I trials were developed to assess the efficacy of
topical corticosteroids and oral acyclovir in treating HSV
stromal keratitis and iridocyclitis.
HEDS-I
consisted of three randomized, placebo-controlled trials.
The organizational structure consisted of a data coordinating
center and eight clinical centers.
All patients received the topical antiviral trifluridine as
prophylaxis against recurrences of HSV epithelial ulceration.
Patients were evaluated weekly for 10 weeks, every other week
through week 16, and again at 6 months. The primary outcome
was the time to development of preset criteria for treatment
failure during the 16-week period of examination. Protocol-specific
descriptions of the three trials follow.
Herpes Stromal Keratitis, Not on Steroid Trial (HEDS-SKN):
Patients with active HSV stromal keratitis who had not used
a topical corticosteroid in the preceding 10 days were randomized
to treatment with topical prednisolone phosphate drops or
topical placebo drops. A treatment schedule, starting with
8 drops a day of 1 percent prednisolone phosphate for 7 days,
was progressively decreased over 10 weeks in such a way that
patients received 1 drop per day of 1/8 percent prednisolone
for the last 3 weeks of treatment. Placebo drops were given
by the same schedule.
Herpes Stromal Keratitis, on Steroid Treatment (HEDS-SKS):
Patients with active HSV stromal keratitis who already were
being treated with a topical corticosteroid were randomized
either to oral treatment with 200 mg acyclovir capsules (400
mg five times daily) for 10 weeks or to the identical dose
of placebo capsules. Patients also received topical prednisolone
phosphate in the dosage schedule described above for the SKN
trial.
Herpes Simplex Virus Iridocyclitis, Receiving Topical Steroids
(HEDS-IRT):
Patients with active HSV iridocyclitis were randomized either
to oral treatment with 200 mg acyclovir capsules (400 mg five
times daily) for 10 weeks or to the identical dose of placebo
capsules. Patients also received topical prednisolone phosphate
in the dosage schedule described above for the SKN trial.
Herpes Stromal
Keratitis, Not on Steroid Trial (HEDS-SKN):
Patient recruitment was stopped on the recommendation of the
Data and Safety Monitoring Committee after 106 of the originally
planned 176 patients were enrolled. Compared with the patients
in the placebo group, the patients who received prednisolone
phosphate drops had faster resolution of the stromal keratitis
and fewer treatment failures. However, delaying the initiation
of corticosteroid treatment did not affect the eventual outcome
of the disease, in that visual acuity was similar in the two
groups at 26 weeks.
Herpes Stromal Keratitis, on Steroid Treatment (HEDS-SKS):
One hundred and four patients were enrolled in this trial.
Over the 16-week followup period, there was no difference
in the rate of treatment failure between the two groups. Thus,
there was no apparent benefit in the addition of oral acyclovir
to the treatment regimen of a topical corticosteroid and a
topical antiviral.
Herpes Simplex Virus Iridocyclitis, Receiving Topical Steroids
(HEDS-IRT):
The trial was stopped because of slow recruitment after only
50 of the originally planned 104 patients were enrolled during
a 4-year recruitment period. Treatment failures occurred at
a higher rate in the placebo group than in the acyclovir group.
Although the number of patients enrolled in this trial was
too small to achieve statistically conclusive results, the
trend in the results suggests a benefit in adding oral acyclovir
to the treatment of HSV iridocyclitis in patients receiving
topical corticosteroids and trifluridine prophylaxis.
Last Updated: 10/21/99
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