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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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PACTR |
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Last refreshed on:
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29 May 2023 |
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Main ID: |
PACTR201701001971511 |
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Date of registration:
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14/01/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Non-steroidal anti-inflammatory drugs vs Steroids in the post operative management of inflammation following uncomplicated cataract surgery
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Scientific title:
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Comparison of topical Non steroidal anti-inflammatory drugs (NSAIDS) and steroids in the post operative management of inflammation following uncomplicated cataract surgery |
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Date of first enrolment:
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09/02/2016 |
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Target sample size:
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100 |
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Recruitment status: |
Complete |
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URL:
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https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=1971 |
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Study type:
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Interventional |
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Study design:
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Parallel: different groups receive different interventions at same time during study,Randomised,Simple randomisation using sealed opaque envelopes,Sealed opaque envelopes
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Phase:
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Not Applicable
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Countries of recruitment
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Nigeria
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Contacts
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Name:
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Olajumoke
Ibidapo |
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Address:
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1-5 Oba akinjobi road
lagos
Nigeria |
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Telephone:
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08033023800 |
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Email:
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viewpoint_ng@yahoo.com |
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Affiliation:
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Chief Consultant |
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Name:
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Ochuko
Egagifo |
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Address:
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1-5 Oba akinjobi road
p.o.box 11338 Ikeja
Ikeja
Nigeria |
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Telephone:
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08034077360 |
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Email:
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ochuko4ever@yahoo.com |
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Affiliation:
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Senior registrar |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1.Patients aged 18yrs and above.
2.Patients who had uncomplicated cataract surgery + intraocular lens implantation.
3.Uneventful surgical procedure i.e. no intra-operative complications like hyphema or vitreous loss which may affect visual outcome.
Exclusion criteria: 1.Patients aged less than 18yrs.
2.Patients who did not require intraocular lens implantation.
3.Patients who had intra-operative complications e.g. posterior capsule rent, hyphema.
4.Patients with previous history of ocular inflammation with signs such as old keratic precipitates.
5.patients with allergic conjunctivitis.
6.patients currently being managed with either steroids or Nsaids.
7.Previous history of intraocular surgery.
8.History of Glaucoma.
Age minimum:
18 Year(s)
Age maximum:
80 Year(s)
Gender:
Both
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Health Condition(s) or Problem(s) studied
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cataract
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Eye Diseases
Surgery
cataract
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Eye Diseases
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Surgery
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Intervention(s)
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Topical Nepafenac 0.1%
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topical Dexamethsone 0.1%
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Primary Outcome(s)
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anterior chamber cells and flare, Intraocular pressure
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Secondary Outcome(s)
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conjunctival congestion, visual acuity, pain
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Secondary ID(s)
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LREC/10/06/519
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Source(s) of Monetary Support
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Department of Ophthalmology, Lagos State University Teaching Hospital.
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Ethics review
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Status: Approved
Approval date: 14/04/2015
Contact:
Health Research and Ethics Committee Lagos State University Teaching Hospital, Ikeja Lagos, Nigeria.
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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