Back to resultsEfficacy and Necessity of Anti-inflammatory Drops After Laser Peripheral Iridotomy
Primary Purpose
Glaucoma, Closed-Angle, Glaucoma, Narrow-Angle, Glaucoma, Angle-Closure
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Dexamethasone Disodium Phosphate 0.1%
Nepafenac 0.1%
Hydroxyethylcellulose 0.19%
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma, Closed-Angle focused on measuring Laser peripheral iridotomy, topical anti-inflammatory drops
Eligibility Criteria
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
Sites / Locations
- Sheba Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
NSAIDs-Placebo
Placebo-NSAIDs
Steroid-Placebo
Placebo-Steroids
Arm Description
Will receive Nepafenac 0.1%in the first eye, and Hydroxyethylcellulose 0.19% in the second eye
Will receive Hydroxyethylcellulose 0.19% in the first eye, and Nepafenac 0.1%in the second eye
Will receive Dexamethasone Disodium Phosphate 0.1% in the first eye, and Hydroxyethylcellulose 0.19% in the second eye
Will receive Hydroxyethylcellulose 0.19%in the first eye, and Dexamethasone Disodium Phosphate 0.1%in the second eye
Outcomes
Primary Outcome Measures
Pain score
Using VAS pain scale
Symptoms score
Using a modified questionnaire based on the ocular surface disease index.
Secondary Outcome Measures
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02955641
Brief Title
Efficacy and Necessity of Anti-inflammatory Drops After Laser Peripheral Iridotomy
Official Title
Efficacy and Necessity of Anti-inflammatory Drops After Laser Peripheral Iridotomy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2016 (Actual)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
November 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheba Medical Center
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Closed-Angle, Glaucoma, Narrow-Angle, Glaucoma, Angle-Closure
Keywords
Laser peripheral iridotomy, topical anti-inflammatory drops
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NSAIDs-Placebo
Arm Type
Active Comparator
Arm Description
Will receive Nepafenac 0.1%in the first eye, and Hydroxyethylcellulose 0.19% in the second eye
Arm Title
Placebo-NSAIDs
Arm Type
Active Comparator
Arm Description
Will receive Hydroxyethylcellulose 0.19% in the first eye, and Nepafenac 0.1%in the second eye
Arm Title
Steroid-Placebo
Arm Type
Active Comparator
Arm Description
Will receive Dexamethasone Disodium Phosphate 0.1% in the first eye, and Hydroxyethylcellulose 0.19% in the second eye
Arm Title
Placebo-Steroids
Arm Type
Active Comparator
Arm Description
Will receive Hydroxyethylcellulose 0.19%in the first eye, and Dexamethasone Disodium Phosphate 0.1%in the second eye
Intervention Type
Drug
Intervention Name(s)
Dexamethasone Disodium Phosphate 0.1%
Other Intervention Name(s)
Sterodex
Intervention Description
four drops a day for four days after LPI treatment
Intervention Type
Drug
Intervention Name(s)
Nepafenac 0.1%
Other Intervention Name(s)
Nevanac
Intervention Description
four drops a day for four days after LPI treatment
Intervention Type
Drug
Intervention Name(s)
Hydroxyethylcellulose 0.19%
Other Intervention Name(s)
Lyteers ophthalmic solution
Intervention Description
four drops a day for four days after LPI treatment
Primary Outcome Measure Information:
Title
Pain score
Description
Using VAS pain scale
Time Frame
At four days post LPI treatment
Title
Symptoms score
Description
Using a modified questionnaire based on the ocular surface disease index.
Time Frame
At four days post LPI treatment
Secondary Outcome Measure Information:
Title
Grading of cells in the anterior chamber
Description
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
Title
Patency of LPI by visualisation
Description
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
Title
Grading of flare in anterior chamber
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ari Leshno, MD
Phone
+972-3-5302874
Email
ari.leshano@sheba.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ari Leshno, MD
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheba Medical Center
City
Tel HaShomer
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ari Leshno
Email
arileshno@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Efficacy and Necessity of Anti-inflammatory Drops After Laser Peripheral Iridotomy
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