Efficacy and Necessity of Anti-inflammatory Drops After Laser Peripheral Iridotomy
NCT ID: NCT02955641
Last Updated: 2018-04-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2016-11-01
2019-11-30
Brief Summary
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Detailed Description
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Anti-inflammatory drops are commonly prescribed to patients undergoing LPI in order to prevent or reduce post-treatment discomfort. However, to date, there are no specific guidelines for post LPI anti-inflammatory treatment, nor sufficient clinical evidence regarding the efficacy of such treatment.
In the current study, the investigators aim to evaluate the effect of topical steroids and non-steroidal anti-inflammatory drugs (NSAIDs) on post LPI symptoms and inflammation markers.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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NSAIDs-Placebo
Will receive Nepafenac 0.1%in the first eye, and Hydroxyethylcellulose 0.19% in the second eye
Nepafenac 0.1%
four drops a day for four days after LPI treatment
Hydroxyethylcellulose 0.19%
four drops a day for four days after LPI treatment
Placebo-NSAIDs
Will receive Hydroxyethylcellulose 0.19% in the first eye, and Nepafenac 0.1%in the second eye
Nepafenac 0.1%
four drops a day for four days after LPI treatment
Hydroxyethylcellulose 0.19%
four drops a day for four days after LPI treatment
Steroid-Placebo
Will receive Dexamethasone Disodium Phosphate 0.1% in the first eye, and Hydroxyethylcellulose 0.19% in the second eye
Dexamethasone Disodium Phosphate 0.1%
four drops a day for four days after LPI treatment
Hydroxyethylcellulose 0.19%
four drops a day for four days after LPI treatment
Placebo-Steroids
Will receive Hydroxyethylcellulose 0.19%in the first eye, and Dexamethasone Disodium Phosphate 0.1%in the second eye
Dexamethasone Disodium Phosphate 0.1%
four drops a day for four days after LPI treatment
Hydroxyethylcellulose 0.19%
four drops a day for four days after LPI treatment
Interventions
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Dexamethasone Disodium Phosphate 0.1%
four drops a day for four days after LPI treatment
Nepafenac 0.1%
four drops a day for four days after LPI treatment
Hydroxyethylcellulose 0.19%
four drops a day for four days after LPI treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able to give consent
* Ability to attend follow-up visits
Exclusion Criteria
* Secondary closed angle (e.g. uveitis related)
* Pregnant women
* Previous eye surgery other than laser refractive correction
18 Years
90 Years
ALL
No
Sponsors
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Sheba Medical Center
OTHER_GOV
Responsible Party
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Principal Investigators
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Ari Leshno, MD
Role: PRINCIPAL_INVESTIGATOR
Sheba Medical Center
Locations
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Sheba Medical Center
Tel Litwinsky, , Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SHEBA-16-3197-AL-CTIL
Identifier Type: -
Identifier Source: org_study_id
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