CataractPhase 2NCT03851172
Nepafenac Versus Ketorolac Eye Drops in Prevention of Intraoperative Miosis During Cataract Surgery
A Phase 2 study testing Ketorolac Ophthalmic, Nepafenac Ophthalmic and Cyclopentolate Ophthalmic in people with Cataract and Miosis, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 days to 80 yearsHealthy volunteers can take part
- What is being tested?
- Ketorolac Ophthalmic, Nepafenac Ophthalmic and Cyclopentolate Ophthalmic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2019to 30 Mar 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 days to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with cataract who are candidate for cataract surgery
Who cannot join
- D.M,
- Patient with other ocular comorbidities rather than cataract,
- Patients with history of trauma.
- Patients on Corticosteroid drops treatment.
- Previous intraocular surgery.
About this study
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.
Read the 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.
- Being tested
- Ketorolac Ophthalmic, Nepafenac Ophthalmic, Cyclopentolate Ophthalmic
- Keywords
- Cataract surgery, Intraoperative Miosis, Ketorolac eye drops, Nepafenac eye drops
- Medical subject headings
- Cataract, Miosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketorolac OphthalmicDrug
Preoperative administration of Ketorolac 0.5% eye drops
Nepafenac OphthalmicDrug
Preoperative administration of Nepafenac 1 mg eye drops
Cyclopentolate OphthalmicDrug
Preoperative administration of Cyclopentolate eye drops
| Study group | Role | What they receive |
|---|---|---|
| Nepafenac and cyclopentolate | Experimental | Nepafenac 1 mg eye drops two times before surgery and cyclopentolate eye drops two times before cataract surgery Receives: 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 Receives: 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 Receives: Drug: Cyclopentolate Ophthalmic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of miosis during cataract surgery
The prevention of intraoperative miosis during cataract surgery after preparation by the different eye drops and cyclopentolate
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2019
- Study start1 Mar 2019 (estimated)
- Primary completion1 Dec 2019 (estimated)
- Study completion30 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omnia Ahmed Mahrous Sayed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03851172
- Sponsor's protocol ID
- 0925-0586
- Status last verified
- Feb 2019
- First submitted
- 21 Feb 2019
- Last updated
- 25 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nepafenac Versus Ketorolac Eye Drops in Prevention of Intraoperative Miosis During Cataract Surgery
- ClinicalTrials.gov ID
- NCT03851172
- Acronym / sponsor ID
- 0925-0586
- Keywords
- Cataract surgery, Intraoperative Miosis, Ketorolac eye drops, Nepafenac eye drops
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (estimated)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 30 Mar 2020 (estimated)
- First posted
- 22 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nepafenac and cyclopentolate | Experimental | Drug: Nepafenac Ophthalmic, Drug: Cyclopentolate OphthalmicNepafenac 1 mg eye drops two times before surgery and cyclopentolate eye drops two times before cataract surgery |
| Ketorolac and cyclopentolate | Experimental | Drug: Ketorolac Ophthalmic, Drug: Cyclopentolate OphthalmicKetorolac 0.5% eye drops two times before surgery and cyclopentolate eye drops two times before cataract surgery |
| Cyclopentolate and saline 0.9% | Placebo comparator | Drug: Cyclopentolate OphthalmicCyclopentolate eye drops two times before surgery and saline 0.9% eye drops two times before cataract surgery |
Who may qualify
- Ages
- 2 days to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with cataract who are candidate for cataract surgery
Key exclusion criteria (5 listed)
- D.M,
- Patient with other ocular comorbidities rather than cataract,
- Patients with history of trauma.
- Patients on Corticosteroid drops treatment.
- Previous intraocular surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketorolac OphthalmicPreoperative administration of Ketorolac 0.5% eye drops | Drug | Ketorolac and cyclopentolate |
| Nepafenac OphthalmicPreoperative administration of Nepafenac 1 mg eye drops | Drug | Nepafenac and cyclopentolate |
| Cyclopentolate OphthalmicPreoperative administration of Cyclopentolate eye drops | Drug | Cyclopentolate and saline 0.9%, Ketorolac and cyclopentolate, Nepafenac and cyclopentolate |
Primary outcome
Prevention of miosis during cataract surgery
Time frame: 30 minutes
The prevention of intraoperative miosis during cataract surgery after preparation by the different eye drops and cyclopentolate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ketorolac Ophthalmic, Nepafenac Ophthalmic and Cyclopentolate Ophthalmic in people with Cataract and Miosis, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevention of miosis during cataract surgery (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2019.