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

Glaucoma, Angle-Closure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02955641
• Other study ID #: SHEBA-16-3197-AL-CTIL
• Status: Recruiting
• Phase: N/A
• First received: September 5, 2016
• Last updated: April 23, 2018
• Start date: November 1, 2016
• Est. completion date: November 2019

Study information

• Verified date: April 2018
• Source: Sheba Medical Center
• Contact: Ari Leshno, MD
• Phone: +972-3-5302874
• Email: ari.leshano[@]sheba.health.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 2019
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Tel HaShomer

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score	Using VAS pain scale	At four days post LPI treatment
Primary	Symptoms score	Using a modified questionnaire based on the ocular surface disease index.	At four days post LPI treatment
Secondary	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	At four days post LPI treatment
Secondary	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	up to 30 days post LPI treatment
Secondary	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	At four days post LPI treatment