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

Sheba Medical Center

Status: Unknown

Conditions: Glaucoma, Narrow-Angle; Glaucoma, Closed-Angle; Glaucoma, Angle-Closure

Treatments: Drug: Dexamethasone Disodium Phosphate 0.1%; Drug: Hydroxyethylcellulose 0.19%; Drug: Nepafenac 0.1%

Study type: Interventional

Funder types: Other

Identifiers

NCT02955641

SHEBA-16-3197-AL-CTIL

Details and patient eligibility

About

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

Full description

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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100 participants in 4 patient groups

NSAIDs-Placebo

Active Comparator group

Description:

Will receive Nepafenac 0.1%in the first eye, and Hydroxyethylcellulose 0.19% in the second eye

Treatment:

Drug: Hydroxyethylcellulose 0.19%

Drug: Nepafenac 0.1%

Placebo-NSAIDs

Active Comparator group

Description:

Will receive Hydroxyethylcellulose 0.19% in the first eye, and Nepafenac 0.1%in the second eye

Treatment:

Drug: Hydroxyethylcellulose 0.19%

Drug: Nepafenac 0.1%

Steroid-Placebo

Active Comparator group

Description:

Will receive Dexamethasone Disodium Phosphate 0.1% in the first eye, and Hydroxyethylcellulose 0.19% in the second eye

Treatment:

Drug: Hydroxyethylcellulose 0.19%

Drug: Dexamethasone Disodium Phosphate 0.1%

Placebo-Steroids

Active Comparator group

Description:

Will receive Hydroxyethylcellulose 0.19%in the first eye, and Dexamethasone Disodium Phosphate 0.1%in the second eye

Treatment:

Drug: Hydroxyethylcellulose 0.19%

Drug: Dexamethasone Disodium Phosphate 0.1%