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.: PACTR201403000487186 Date of Registration: 18/01/2013
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title EFFECT OF SUBCONJUCTIVAL DEXAMETHASONE INJECTION ON POST-OP INFLAMATION AFTER CATARACT SURGERY (SICS)
Official scientific title EFFECT OF SUBCONJUCTIVAL DEXAMETHASONE INJECTION ON POST-OP INFLAMATION AFTER CATARACT SURGERY (SICS)
Brief summary describing the background and objectives of the trial Cataract is the leading cause of blindness,the only treatment for it, is catract extraction.Post operative inflammation is a natural sequel of the surgery which is treated maily by topical steroid for a 6 week course. one of the common practices is to give subconjuctival dexamethasone injection on the table after the surgery, is not an evidence based practice.and carry side effects.The objective is to determine if subconjuctival dexamethasone injection post SICS has an effect on inflammation
Type of trial RCT
Acronym (If the trial has an acronym then please provide) SICS
Disease(s) or condition(s) being studied Cataract
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/04/2013
Actual trial start date
Anticipated date of last follow up 30/04/2013
Actual Last follow-up date
Anticipated target sample size (number of participants) 167
Actual target sample size (number of participants) 167
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised A random set of numbers was generated using a Microsoft excel program and a random number was assigned for each patient. The correspondence between the numbers and the assigned patients followed odd and even pattern. Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Dexamethasone 2mg/0.5 ml once an subconjuctival injection of steroid 53 Placebo
Control Group Gentamicin-normal saline injection Gentamincin dose was 20mg/0.5ml, normal saline dose was 0.5 ml Once.adminstrated immediatly after cataract surgery completion A subconjuctival injection 56 Placebo
Experimental Group A combination of dexamethasone-gentamicin injection Dexamthasone dose was 2mg/0.5 ml.Gentamicin dose was 20mg/0.5ml Once.adminstrated immediatly after cataract surgery completion A subconjuctival injection 58 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ Age: >40yrs ¿ Race: Blacks ¿ Patients who are planned for suture less small incision cataract surgery with posterior chamber IOL implantation and who have no pre-existing risk factors/intraoperative complications. ¿ Patients who will give a written informed consent 1 Preoperative ¿ Patients with glaucoma ¿ Active intraocular infection or inflammation ¿ Previous ocular surgery in the index eye ¿ Diabetes mellitus. ¿ History of uveitis ¿ Pre-operative Anterior or Posterior synechiae ¿ Pre-existing ocular surface disease ¿ Traumatic cataract¿ Pediatric cataract 2-Intraoperative ¿ Iris prolapse ¿ Shallow anterior chamber ¿ Remnants of cortex ¿ Sphincter tear ¿ Iridodialysis ¿ Large remnants of viscoelastic material ¿ Zonular dialysis/rupture without vitreous loss ¿ Rupture of posterior capsule without vitreous ¿ Rupture of posterior capsule with vitreous loss ¿ Nucleus dislocated into vitreous ¿ Zonular dialysis/rupture with vitreous loss4.6.3 3-Post operative: ¿ Corneal edema with IOP> 30mmHg ¿ Iris prolapse Shallow anterior Chamber ¿ Descement s folds >10 ¿ Wound leak ¿ Hypopyon ¿ Hyphema ¿ Decentered pupil ¿ Malposition of haptic ¿ Retained lens matter 40 Year(s) 90 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 10/01/2013 Kenyatta National Hospital/university Of Nairobi - Ethics & Research Committee
Ethics Committee Address
Street address City Postal code Country
Mbagathi road Nairobi PO box 19676-00202 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome evaluating post cataract surgery inflammation following Standardization of Uveitis Nomenclature (SUN) Working Group Grading Scheme for Anterior Chamber Cells and Flare outcome is meaured at first and second post operative days
Primary Outcome Anterior chamber cells and flare measurements on the first and the second postoperative days. Primary outcome was meaured on the first post operative day (which is defined as 24 ± 4h after the completion of cataract surgery) and on the second postoperative day. No secondary outcomes were measured.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lions Sight First Eye Hospital Kaptagat Road Loresho Nairobi P.O Box 66576,00800 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr sandra aldaoud church road off rhapta road Nairobi 55040-00200 Kenya
Self sponsered.Dr Sandra Adnan Aldaoud Rhapta Road, Westlands. Nairobi PO Box 55040 - 0020 Kenya
Self sponsered.Dr Sandra Adnan Aldaoud Rhapta Road, Westlands. Nairobi PO Box 55040 - 0020 Kenya
Self sponsered.Dr Sandra Adnan Aldaoud Church road off Rhapta Road, Westlands. Nairobi PO Box 55040 - 0020 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr sandra aldaoud church road off rhapta road Nairobi 55040-00200 Kenya Charities/Societies/Foundation
Primary Sponsor Dr sandra aldaoud church road off rhapta road Nairobi 55040-00200 Kenya University
COLLABORATORS
Name Street address City Postal code Country
Dr. jyotte
Dr. jyotte loresho nairobi 66576-00800 Kenya
Dr. jyotte loresho nairobi 66576-00800 Kenya
Dr. jyotte loresho nairobi 66576-00800 Kenya
Dr. jyotte trivedy Kaptagat Road, Loresho Nairobi PO box 66576-00800 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Dr Sandra Aldaoud sandraadnan@gmail.com +254737860094 church road off rhapta road
City Postal code Country Position/Affiliation
Nairobi 55040-00200 Kenya Completed MMED in Opthalomology
Role Name Email Phone Street address
Public Enquiries Dr. Aleksandar Galev alexgalev@yahoo.com +254722200959 Church road off rhapta road
City Postal code Country Position/Affiliation
Nairobi 55040-00200 Kenya A medical doctor
Role Name Email Phone Street address
Public Enquiries Aleksandar galev alexgalev@yahoo.com +254722200959 church road off rhapta road
City Postal code Country Position/Affiliation
Nairobi 55040-00200 Kenya A medical doctor
Role Name Email Phone Street address
Scientific Enquiries Dr. Jyotte Trivedy jyoteeye@lionsloresho.org +254728970601 Kaptagat Road , Loresho
City Postal code Country Position/Affiliation
Nairobi P.O. Box: 66576 Kenya An ophthalmologist and cataract surgeon
REPORTING
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