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.: PACTR201605001575408 Date of Registration: 08/04/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison of Visian toric collamer lens and Acrysof Toric lens implantation for treatment of myopic astigmatism
Official scientific title Comparison of Visian toric collamer lens and Acrysof Toric lens implantation for myopic astigmatism treatment
Brief summary describing the background and objectives of the trial To compare the efficacy and outcome of phakic Visian toric implantable collamer lens (PTICL) and refractive clear lens extraction with toric AcrySof intraocular lens implantation (TIOL) for the treatment of myopic astigmatism.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Myopic astigmatism
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/08/2013
Actual trial start date 01/08/2013
Anticipated date of last follow up 01/07/2015
Actual Last follow-up date 01/08/2015
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants)
Recruitment status Completed
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
Parallel: different groups receive different interventions at same time during study Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group surgical implantation of phakic posterior chamber toric intraocular lens of the Visian type implantation of tori phakic intraocular posterior chamber lens to correct myopic astigmatism 34
Experimental Group refractive lens extraction with toric intraocular lend implantation phacoemulsification of the crystalline lens with posterior chamber toric Acrysof implantation 29 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-Age between 21 and 45 years with stable refraction for at least one year who were seeking surgical correction of their myopic astigmatism. -Myopic astigmatism with spherical equivalent more than 10 diopters (D) -Myopic astigmatism with spherical equivalent of less than 10 D if the patients were unsuitable for corneal refractive surgery according to guidelines suggested in literature. -Astigmatism more than 1.00 D and less than or equal to 4.00 D . For Toric ICL cases, the anterior chamber depth (ACD) was required to be more than 280 µm from the endothelium in measurements by Pentacam, -Any ocular disease other than myopic astigmatism (cataract, glaucoma, corneal opacities, uveitis, retinal disorders). -History of any ocular surgery. -Corneal endothelial cell count less than 2500 cell/mm as measured by specular microscopy. 21 Year(s) 45 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 18/06/2013 sohag faculty of medicine medical ethics committee
Ethics Committee Address
Street address City Postal code Country
naser city sohag 82524 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome postoperative astigmatism 6 months
Primary Outcome postoperative vector analysis of astigmatism 6 months
Primary Outcome postoperative refracion 6 months
Secondary Outcome postoperative visual acuity 6 months
Secondary Outcome postoperative Intraocular pressure 6 months
Secondary Outcome endothelial cell count changes 6 months
Secondary Outcome intraopertative complications same day
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Sohag university hospital naser city sohag 82524 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
sohag faculty of medicine naser city sohag 82524 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor sohag faculty of medicine naser city sohag 82524 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Anbar naser city, faculty of medicine sohag 82524 Egypt
Marwa M. Abdellah naser city, faculty of medicine sohag 82524 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hatem Ammar htmammar@yahoo.com +201140000324 naser city , faculty of medicine
City Postal code Country Position/Affiliation
sohag 82524 Egypt Assistant professor
Role Name Email Phone Street address
Public Enquiries Hatem Ammar htmammar@yahoo.com +201140000324 naser city , faculty of medicine
City Postal code Country Position/Affiliation
sohag 82524 Egypt Assistant professor
Role Name Email Phone Street address
Scientific Enquiries Hatem Ammar htmammar@yahoo.com +201140000324 naser city , faculty of medicine
City Postal code Country Position/Affiliation
sohag 82524 Egypt Assistant professor
REPORTING
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