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

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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03851172
Enrollment
75
Registered
2019-02-22
Start date
2019-03-01
Completion date
2020-03-30
Last updated
2019-02-25

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

Conditions

Cataract, Miosis

Keywords

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

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.

Detailed 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.

Interventions

DRUGKetorolac Ophthalmic

Preoperative administration of Ketorolac 0.5% eye drops

Preoperative administration of Nepafenac 1 mg eye drops

DRUGCyclopentolate Ophthalmic

Preoperative administration of Cyclopentolate eye drops

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)

Masking description

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.

Eligibility

Sex/Gender
ALL
Age
2 Days to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Prevention of miosis during cataract surgery30 minutesThe prevention of intraoperative miosis during cataract surgery after preparation by the different eye drops and cyclopentolate

Outcome results

None listed

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