Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201701001971511 Date of Approval: 14/01/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Non-steroidal anti-inflammatory drugs vs Steroids in the post operative management of inflammation following uncomplicated cataract surgery
Official scientific title Comparison of topical Non steroidal anti-inflammatory drugs (NSAIDS) and steroids in the post operative management of inflammation following uncomplicated cataract surgery
Brief summary describing the background and objectives of the trial Cataract surgery is the most common intraocular surgery worldwide. It is mandatory for every cataract surgery patient to be placed on an anti-inflammatory drug post-operatively in order to control inflammation. Presently steroids are still the class of drugs advocated for the treatment of ocular inflammation, despite possibility of unwanted ocular side effects such as increase in intraocular pressure. It may therefore be therapeutically beneficial to institute NSAIDS in controlling intraocular inflammation, with less ocular side effects and financially friendly to the patient. This researcher has noticed a rising number of patients with elevated intraocular pressure following cataract surgery using steroids, there is also the cost difference between the steroids and NSAIDs, most steroid eye drops being more costly than NSAIDs. Currently there is scarcity of eye health survey data concerning the management of Nigerians following cataract surgery with NSAIDS compared to steroids. The comparative study done in Nigeria in 2004 between Diclofenac and Dexamethasone showed that Diclofenac 1% was as effective as Prednisolone 1% in controlling inflammation .This study didn¿t take into cognizance the effect on the intraocular by the drugs. There are new Nsaids available which in addition to being potent anti-inflammatory agents, also prevent post-operative Cystoid macula oedema and are more comfortable following use by patients. Nepafenac is the only NSAID produced as a pro-drug and this design maximizes its efficacy at intraocular sites unlike conventional NSAIDs which accumulate at ocular surfaces and decrease in activity with intra-ocular penetration. This study therefore attempts to compare the efficacy and safety of Nepafenac 0.1% (NSAID) and Dexamethasone 0.1% the more commonly used steroid in the management of inflammation following uncomplicated cataract surgery using a prospective randomized controlled clinical trial.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied cataract,Eye Diseases,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 09/02/2016
Actual trial start date
Anticipated date of last follow up 31/10/2016
Actual Last follow-up date 25/11/2016
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
LREC/10/06/519 Health Research and Ethics Committee Lagos State University Teaching Hospital, Ikeja Lagos, Nigeria.
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using sealed opaque envelopes Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Topical Nepafenac 0.1% 4 times daily for 28 days then 3 times daily for 14 days total of 56 days anti-inflammatory control 50 Active-Treatment of Control Group
Control Group topical Dexamethsone 0.1% 4 times daily for 28 days then 3 times daily for 14 days then 2 times daily for 14 days 56 days anti-inflammatory control 50 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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. 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. 18 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 14/04/2015 Health Research and Ethics Committee Lagos State University Teaching Hospital, Ikeja Lagos, Nigeria.
Ethics Committee Address
Street address City Postal code Country
1-5 Oba Akinjobi road Ikeja P.M.B 21005 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome anterior chamber cells and flare, Intraocular pressure 1st day post-operation 7th day post-operation 14th day post-operation 28th day post-operation 56th day post-operation
Secondary Outcome conjunctival congestion, visual acuity, pain 1st day post-operation 7th day post-operation 14th day post-operation 28th day post-operation 56th day post-operation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lagos State University Teaching Hospital 1-5 Oba Akinjobi road Ikeja P.M.B 21005. Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Department of Ophthalmology, Lagos State University Teaching Hospital. 1-5 Oba Akinjobi road Ikeja P.M.B 21005. Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Egagifo Ochuko 1-5 Oba Akinjobi road Ikeja P.O.BOX 11338 Ikeja Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
Dr Egagifo Ochuko 1-5 Oba Akinjobi road Ikeja P.O.BOX 11338 Ikeja Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ochuko Egagifo ochuko4ever@yahoo.com 08034077360 1-5 Oba akinjobi road
City Postal code Country Position/Affiliation
Ikeja p.o.box 11338 Ikeja Nigeria Senior registrar
Role Name Email Phone Street address
Public Enquiries Ochuko Egagifo ochuko4ever@yahoo.com 08034077360 1-5 Oba akinjobi road
City Postal code Country Position/Affiliation
Ikeja p.o.box 11338 Ikeja Nigeria Senior registrar
Role Name Email Phone Street address
Scientific Enquiries Olajumoke Ibidapo viewpoint_ng@yahoo.com 08033023800 1-5 Oba akinjobi road
City Postal code Country Position/Affiliation
lagos Nigeria Chief Consultant
REPORTING
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Result URL Hyperlinks
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