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

Sponsor
Sheba Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT02955641
Collaborator
(none)
100
Enrollment
1
Location
4
Arms
36
Anticipated Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Dexamethasone Disodium Phosphate 0.1%
  • Drug: Nepafenac 0.1%
  • Drug: Hydroxyethylcellulose 0.19%
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Efficacy and Necessity of Anti-inflammatory Drops After Laser Peripheral Iridotomy
Actual Study Start Date :
Nov 1, 2016
Anticipated Primary Completion Date :
Nov 1, 2018
Anticipated Study Completion Date :
Nov 1, 2019

Arms and Interventions

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: Dexamethasone Disodium Phosphate 0.1%
    four drops a day for four days after LPI treatment
    Other Names:
  • Sterodex

    • Drug: Hydroxyethylcellulose 0.19%
    four drops a day for four days after LPI treatment
    Other Names:
  • Lyteers ophthalmic solution

    		•
    Active Comparator: Placebo-Steroids

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

    Drug: Dexamethasone Disodium Phosphate 0.1%
    four drops a day for four days after LPI treatment
    Other Names:
  • Sterodex

    • Drug: Hydroxyethylcellulose 0.19%
    four drops a day for four days after LPI treatment
    Other Names:
  • Lyteers ophthalmic solution

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pain score [At four days post LPI treatment]

      Using VAS pain scale

    2. Symptoms score [At four days post LPI treatment]

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

    Secondary Outcome Measures

    1. Grading of cells in the anterior chamber [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

    2. Patency of LPI by visualisation [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

    3. Grading of flare in anterior chamber [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sheba Medical Center Tel HaShomer Israel

    Sponsors and Collaborators

    • Sheba Medical Center

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sheba Medical Center
    ClinicalTrials.gov Identifier:
    NCT02955641
    Other Study ID Numbers:
    • SHEBA-16-3197-AL-CTIL
    First Posted:
    Nov 4, 2016
    Last Update Posted:
    Apr 24, 2018
    Last Verified:
    Apr 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Sheba Medical Center
    Laser peripheral iridotomy
    topical anti-inflammatory drops
    Additional relevant MeSH terms:
    Glaucoma
    Glaucoma, Angle-Closure
    Dexamethasone
    Nepafenac
    Ophthalmic Solutions

    Study Results

    No Results Posted as of Apr 24, 2018