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

April 23, 2018 updated by: Sheba Medical Center
The purpose of this study is to evaluate the efficacy and need for prescribing anti-inflammatory topical drops to patients undergoing laser peripheral iridotomy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: NSAIDs-Placebo
Will receive Nepafenac 0.1%in the first eye, and Hydroxyethylcellulose 0.19% in the second eye
Drug: Nepafenac 0.1%
four drops a day for four days after LPI treatment
Other Names:
  • Nevanac
Drug: Hydroxyethylcellulose 0.19%
four drops a day for four days after LPI treatment
Other Names:
  • Lyteers ophthalmic solution
Active Comparator: Placebo-NSAIDs
Will receive Hydroxyethylcellulose 0.19% in the first eye, and Nepafenac 0.1%in the second eye
Drug: Nepafenac 0.1%
four drops a day for four days after LPI treatment
Other Names:
  • Nevanac
Drug: Hydroxyethylcellulose 0.19%
four drops a day for four days after LPI treatment
Other Names:
  • Lyteers ophthalmic solution
Active Comparator: Steroid-Placebo
Will receive Dexamethasone Disodium Phosphate 0.1% in the first eye, and Hydroxyethylcellulose 0.19% in the second eye
Drug: Hydroxyethylcellulose 0.19%
four drops a day for four days after LPI treatment
Other Names:
  • Lyteers ophthalmic solution
Drug: Dexamethasone Disodium Phosphate 0.1%
four drops a day for four days after LPI treatment
Other Names:
  • Sterodex
Active Comparator: Placebo-Steroids
Will receive Hydroxyethylcellulose 0.19%in the first eye, and Dexamethasone Disodium Phosphate 0.1%in the second eye
Drug: Hydroxyethylcellulose 0.19%
four drops a day for four days after LPI treatment
Other Names:
  • Lyteers ophthalmic solution
Drug: Dexamethasone Disodium Phosphate 0.1%
four drops a day for four days after LPI treatment
Other Names:
  • Sterodex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain score
Time Frame: At four days post LPI treatment
Using VAS pain scale
At four days post LPI treatment
Symptoms score
Time Frame: At four days post LPI treatment
Using a modified questionnaire based on the ocular surface disease index.
At four days post LPI treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Grading of cells in the anterior chamber
Time Frame: At four days post LPI treatment
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
Patency of LPI by visualisation
Time Frame: up to 30 days post LPI treatment
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
Grading of flare in anterior chamber
Time Frame: At four days post LPI treatment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Investigators

  • Principal Investigator: Ari Leshno, MD, Sheba Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Anticipated)

November 1, 2018

Study Completion (Anticipated)

November 1, 2019

Study Registration Dates

First Submitted

September 5, 2016

First Submitted That Met QC Criteria

November 2, 2016

First Posted (Estimate)

November 4, 2016

Study Record Updates

Last Update Posted (Actual)

April 24, 2018

Last Update Submitted That Met QC Criteria

April 23, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-16-3197-AL-CTIL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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