Efficacy and Necessity of Anti-inflammatory Drops After Laser Peripheral Iridotomy

NCT ID: NCT02955641

Last Updated: 2018-04-24

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-01

Study Completion Date

2019-11-30

Brief Summary

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The purpose of this study is to evaluate the efficacy and need for prescribing anti-inflammatory topical drops to patients undergoing laser peripheral iridotomy.

Detailed Description

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Primary closed angle glaucoma is responsible to almost half glaucoma related blindness around the world. Laser peripheral iridotomy (LPI) is a common and simple treatment used for both treatment and prevention of acute angle closure event.

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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Glaucoma, Closed-Angle Glaucoma, Narrow-Angle Glaucoma, Angle-Closure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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

Group Type ACTIVE_COMPARATOR

Nepafenac 0.1%

Intervention Type DRUG

four drops a day for four days after LPI treatment

Hydroxyethylcellulose 0.19%

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

Nepafenac 0.1%

Intervention Type DRUG

four drops a day for four days after LPI treatment

Hydroxyethylcellulose 0.19%

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

Dexamethasone Disodium Phosphate 0.1%

Intervention Type DRUG

four drops a day for four days after LPI treatment

Hydroxyethylcellulose 0.19%

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

Dexamethasone Disodium Phosphate 0.1%

Intervention Type DRUG

four drops a day for four days after LPI treatment

Hydroxyethylcellulose 0.19%

Intervention Type DRUG

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

Intervention Type DRUG

Nepafenac 0.1%

four drops a day for four days after LPI treatment

Intervention Type DRUG

Hydroxyethylcellulose 0.19%

four drops a day for four days after LPI treatment

Intervention Type DRUG

Other Intervention Names

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Sterodex Nevanac Lyteers ophthalmic solution

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of primary narrow/closed angle by gonioscopy
* Able to give consent
* Ability to attend follow-up visits

Exclusion Criteria

* Corneal disease preventing sufficient evaluation of the angle
* Secondary closed angle (e.g. uveitis related)
* Pregnant women
* Previous eye surgery other than laser refractive correction
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Ari Leshno, MD

Role: CONTACT

+972-3-5302874

Facility Contacts

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Ari Leshno

Role: primary

Other Identifiers

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SHEBA-16-3197-AL-CTIL

Identifier Type: -

Identifier Source: org_study_id

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