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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02955641
Enrollment
100
Registered
2016-11-04
Start date
2016-11-01
Completion date
2019-11-30
Last updated
2018-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Laser peripheral iridotomy, topical anti-inflammatory drops

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.

Interventions

DRUGDexamethasone Disodium Phosphate 0.1%

four drops a day for four days after LPI treatment

four drops a day for four days after LPI treatment

DRUGHydroxyethylcellulose 0.19%

four drops a day for four days after LPI treatment

Sponsors

Sheba Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Pain scoreAt four days post LPI treatmentUsing VAS pain scale
Symptoms scoreAt four days post LPI treatmentUsing a modified questionnaire based on the ocular surface disease index.

Secondary

MeasureTime frameDescription
Grading of cells in the anterior chamberAt four days post LPI treatmentAssessed 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 visualisationup to 30 days post LPI treatmentAssessed 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 chamberAt four days post LPI treatmentAssessed by counting the number of cells in the anterior chamber and applying the SUN working group grading scheme for anterior chamber flare

Countries

Israel

Contacts

Primary ContactAri Leshno, MD
ari.leshano@sheba.health.gov.il+972-3-5302874

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026