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

Sheba Medical Center100 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

100

Conditions

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

Interventions

Dexamethasone Disodium Phosphate 0.1%DRUG

four drops a day for four days after LPI treatment

Nepafenac 0.1%DRUG

four drops a day for four days after LPI treatment

Hydroxyethylcellulose 0.19%DRUG

four drops a day for four days after LPI treatment

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Sheba Medical Center

Tel Litwinsky, Israel

RECRUITING

Outcomes

Primary Outcomes

Pain score

Using VAS pain scale

Time frame: At four days post LPI treatment

Symptoms score

Using a modified questionnaire based on the ocular surface disease index.

Time frame: At four days post LPI treatment

Secondary Outcomes

Grading of cells in the anterior chamber

Assessed by counting the number of cells in the anterior chamber and applying the SUN working group grading scheme for anterior chamber cells

Time frame: At four days post LPI treatment

Patency of LPI by visualisation

Assessed on slit-lamp examination using transilumination and visualising the site of LPI treatment for the presence (patent) or obsence (closed) of transilumination defect

Time frame: up to 30 days post LPI treatment

Grading of flare in anterior chamber

Assessed by counting the number of cells in the anterior chamber and applying the SUN working group grading scheme for anterior chamber flare

Time frame: At four days post LPI treatment

Central Contacts

Ari Leshno, MD

CONTACT

+972-3-5302874 ari.leshano@sheba.health.gov.il

Data from ClinicalTrials.gov

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