Nepafenac Versus Ketorolac Eye Drops in Prevention of Intraoperative Miosis During Cataract Surgery

NCT03851172 | Unknown Phase 2

• 1 other identifier: 0925-0586
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aim at determining the efficacy of Nepafenac and Ketorolac in obtaining adequate intraoperative mydriasis and preventing miosis during cataract surgery. It also compare the efficacy of both Nepafenac versus Ketorolac, and determine the more effective agent in preventing miosis during cataract surgery. The investigators try to determine if the effect of preoperative NSAIDs agents use would show a financial benefit, or this manoeuvre would add a financial load on the patients who are candidate for cataract surgery.

Conditions

Cataract; Miosis

Keywords

Cataract surgery; Intraoperative Miosis; Ketorolac eye drops; Nepafenac eye drops

Outcome Measures

Primary Outcomes (1)

• Prevention of miosis during cataract surgery

  The prevention of intraoperative miosis during cataract surgery after preparation by the different eye drops and cyclopentolate

  30 minutes

Study Arms (3)

Nepafenac and cyclopentolate

EXPERIMENTAL

Nepafenac 1 mg eye drops two times before surgery and cyclopentolate eye drops two times before cataract surgery

Drug: Nepafenac Ophthalmic; Drug: Cyclopentolate Ophthalmic

Ketorolac and cyclopentolate

EXPERIMENTAL

Ketorolac 0.5% eye drops two times before surgery and cyclopentolate eye drops two times before cataract surgery

Drug: Ketorolac Ophthalmic; Drug: Cyclopentolate Ophthalmic

Cyclopentolate and saline 0.9%

PLACEBO COMPARATOR

Cyclopentolate eye drops two times before surgery and saline 0.9% eye drops two times before cataract surgery

Drug: Cyclopentolate Ophthalmic

Interventions

Ketorolac Ophthalmic DRUG

Preoperative administration of Ketorolac 0.5% eye drops

Ketorolac and cyclopentolate

Nepafenac Ophthalmic DRUG

Preoperative administration of Nepafenac 1 mg eye drops

Nepafenac and cyclopentolate

Cyclopentolate Ophthalmic DRUG

Preoperative administration of Cyclopentolate eye drops

Cyclopentolate and saline 0.9%; Ketorolac and cyclopentolate; Nepafenac and cyclopentolate

Eligibility Criteria

• Age: 2 Days - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with cataract who are candidate for cataract surgery

You may not qualify if:

• D.M,
• Patient with other ocular comorbidities rather than cataract,
• Patients with history of trauma.
• Patients on Corticosteroid drops treatment.
• Previous intraocular surgery.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Cataract; Miosis

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Pupil Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Allocation concealment will be achieved by masking the bottles of the different agents which will be used in the study. All agents will be added to non-labeled bottles, then they will be labeled by the supervisor (who will not participate in eye drops administration) as bottle (1), bottle (2) and bottle (3). The most junior researcher will be responsible for the eye drops administration, for whom the different agents are not known.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at ophthalmology department

Study Record Dates

• First Submitted: February 21, 2019
• First Posted: February 22, 2019
• Study Start: March 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: March 30, 2020
• Last Updated: February 25, 2019

Record last verified: 2019-02