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

Assiut University

Status and phase: Unknown; Phase 2

Conditions: Cataract; Miosis

Treatments: Drug: Cyclopentolate Ophthalmic; Drug: Nepafenac Ophthalmic; Drug: Ketorolac Ophthalmic

Study type: Interventional

Funder types: Other

Identifiers

NCT03851172

0925-0586

Details and patient eligibility

About

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.

Full description

Maintaining adequate mydriasis is one of the most important prerequisites during both extracapsular cataract extraction and phacoemulsification intervention. The importance of intraoperative maintenance of mydriasis arises from the necessity for the surgeon to insert intra-ocular lens in the posterior chamber of the eye. It is now well established that non-steroidal anti-inflammatory drugs (NSAIDs) reduce intraoperative miosis during cataract surgery. Topical Flurbiprofen, Indomethacin and Diclofenac with and without intraoperative epinephrine are the commonest topical non-steroidal eye drops with which nearly all publications in the literature studied the prevention of intraoperative surgery-induced miosis. In addition, Diclofenac was found to be the most effective NSAIDs agent in maintaining intraoperative mydriasis.

More recently, evidence that some NSAIDs, namely ketorolac and Flurbiprofen, may have a role in preventing pseudophakic cystoid macular oedema.

Patients whom eyes are pre-treated with some NSAIDs, especially diclofenac, shows a statistically significant reduction in the degree of postoperative inflammation (e.g., redness, pain and itching) on the first post-operative day. On the contrary, Thaller et al found, in his study at 2000, that no statistically significant difference in the postoperative redness, pain and cells in the anterior chamber.

Administration of Adrenalin in the anterior chamber fluid is found by several studies to be more effective in maintaining intraoperative mydriasis than preoperative treatment with NSAIDs.

Enrollment: 75 estimated patients

Sex: All

Ages: 2 days to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients with cataract who are candidate for cataract surgery

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 3 patient groups, including a placebo group

Nepafenac and cyclopentolate

Experimental group

Description:

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

Treatment:

Drug: Cyclopentolate Ophthalmic

Drug: Nepafenac Ophthalmic

Ketorolac and cyclopentolate

Experimental group

Description:

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

Treatment:

Drug: Ketorolac Ophthalmic

Drug: Cyclopentolate Ophthalmic

Cyclopentolate and saline 0.9%

Placebo Comparator group

Description:

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

Treatment:

Drug: Cyclopentolate Ophthalmic