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

NCT02955641 | Unknown

• 1 other identifier: SHEBA-16-3197-AL-CTIL
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Laser peripheral iridotomy; topical anti-inflammatory drops

Outcome Measures

Primary Outcomes (2)

• Pain score

  Using VAS pain scale

  At four days post LPI treatment

• Symptoms score

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

  At four days post LPI treatment

Secondary Outcomes (3)

• Grading of cells in the anterior chamber

  At four days post LPI treatment

• Patency of LPI by visualisation

  up to 30 days post LPI treatment

• Grading of flare in anterior chamber

  At four days post LPI treatment

Study Arms (4)

NSAIDs-Placebo

ACTIVE COMPARATOR

Will receive Nepafenac 0.1%in the first eye, and Hydroxyethylcellulose 0.19% in the second eye

Drug: Nepafenac 0.1%; Drug: Hydroxyethylcellulose 0.19%

Placebo-NSAIDs

ACTIVE COMPARATOR

Will receive Hydroxyethylcellulose 0.19% in the first eye, and Nepafenac 0.1%in the second eye

Drug: Nepafenac 0.1%; Drug: Hydroxyethylcellulose 0.19%

Steroid-Placebo

ACTIVE COMPARATOR

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%; Drug: Hydroxyethylcellulose 0.19%

Placebo-Steroids

ACTIVE COMPARATOR

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%; Drug: Hydroxyethylcellulose 0.19%

Interventions

Dexamethasone Disodium Phosphate 0.1% DRUG

four drops a day for four days after LPI treatment

Also known as: Sterodex

Placebo-Steroids; Steroid-Placebo

Nepafenac 0.1% DRUG

four drops a day for four days after LPI treatment

Also known as: Nevanac

NSAIDs-Placebo; Placebo-NSAIDs

Hydroxyethylcellulose 0.19% DRUG

four drops a day for four days after LPI treatment

Also known as: Lyteers ophthalmic solution

NSAIDs-Placebo; Placebo-NSAIDs; Placebo-Steroids; Steroid-Placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of primary narrow/closed angle by gonioscopy
• Able to give consent
• Ability to attend follow-up visits

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Tel Litwinsky, Israel

RECRUITING

MeSH Terms

Conditions

Glaucoma, Angle-Closure

Interventions

nepafenac

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Study Officials

• Ari Leshno, MD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ari Leshno, MD

CONTACT

+972-3-5302874; ari.leshano@sheba.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2016
• First Posted: November 4, 2016
• Study Start: November 1, 2016
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2019
• Last Updated: April 24, 2018

Record last verified: 2018-04

Locations

IL (1)