Efficacy and Necessity of Anti-inflammatory Drops After Laser Peripheral Iridotomy
- Conditions
- Glaucoma, Closed-AngleGlaucoma, Narrow-AngleGlaucoma, Angle-Closure
- Interventions
- Registration Number
- NCT02955641
- Lead Sponsor
- Sheba Medical Center
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- Diagnosis of primary narrow/closed angle by gonioscopy
- Able to give consent
- Ability to attend follow-up visits
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Steroid-Placebo Dexamethasone Disodium Phosphate 0.1% Will receive Dexamethasone Disodium Phosphate 0.1% in the first eye, and Hydroxyethylcellulose 0.19% in the second eye Placebo-Steroids Dexamethasone Disodium Phosphate 0.1% Will receive Hydroxyethylcellulose 0.19%in the first eye, and Dexamethasone Disodium Phosphate 0.1%in the second eye Placebo-Steroids Hydroxyethylcellulose 0.19% Will receive Hydroxyethylcellulose 0.19%in the first eye, and Dexamethasone Disodium Phosphate 0.1%in the second eye Placebo-NSAIDs Hydroxyethylcellulose 0.19% Will receive Hydroxyethylcellulose 0.19% in the first eye, and Nepafenac 0.1%in the second eye Steroid-Placebo Hydroxyethylcellulose 0.19% Will receive Dexamethasone Disodium Phosphate 0.1% in the first eye, and Hydroxyethylcellulose 0.19% in the second eye NSAIDs-Placebo Nepafenac 0.1% Will receive Nepafenac 0.1%in the first eye, and Hydroxyethylcellulose 0.19% in the second eye NSAIDs-Placebo Hydroxyethylcellulose 0.19% Will receive Nepafenac 0.1%in the first eye, and Hydroxyethylcellulose 0.19% in the second eye Placebo-NSAIDs Nepafenac 0.1% Will receive Hydroxyethylcellulose 0.19% in the first eye, and Nepafenac 0.1%in the second eye
- Primary Outcome Measures
Name Time Method Pain score At four days post LPI treatment Using VAS pain scale
Symptoms score At four days post LPI treatment Using a modified questionnaire based on the ocular surface disease index.
- Secondary Outcome Measures
Name Time Method 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
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
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
Trial Locations
- Locations (1)
Sheba Medical Center
🇮🇱Tel HaShomer, Israel