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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201901915930254 Date of Registration: 17/01/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Outcomes of primary piggybag versus secondary Iris claw intraocular lens in posterior microphthalmos
Official scientific title Outcomes of primary piggybag versus secondary Iris claw intraocular lens in posterior microphthalmos
Brief summary describing the background and objectives of the trial posterior microphthalmos represents a challenge during cataract surgery especially the calculation of IOL power.The aim of this study is to compare the refractive outcome of primary piggybag IOL and secondary Iris claw lens
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Eye Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/01/2012
Actual trial start date 19/10/2018
Anticipated date of last follow up 01/03/2018
Actual Last follow-up date 19/10/2018
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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 Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group primary piggybag versus secondary Iris claw intraocular lens 2 years follow up after surgery cataract removal by phacoemulsification and IOL implantation 30 Active-Treatment of Control Group
Experimental Group iris claw lens 2 years surgery 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
posterior microphthalmos cataract nuclear or posterior subcapsular with corrected distant visual acuity less than 0.5 on decimal Snellen chart glaucoma corneal opacity macular scar Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 64 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 20/09/2018 ethics committee faculty of medicine Alexandria university
Ethics Committee Address
Street address City Postal code Country
faculty of medicine Alexandria university El Mesala street Alexandria 21500 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome post operative spherical equivalent error one month,one year and 2 years
Secondary Outcome mean absolute error ,UDVA and CDVA 1 month,1 year and 2 years
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
I care center Somouha,14 May bridge street alexandria 21500 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self funded Sultan Hussein street Alexandria 21500 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Abdelhameed El hofi Sidi gaber tram station alexandria 21500 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
abdelhameed elhofi sidi gaber street alexandria 21500 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hany Helaly hany209209@yahoo.com +201225466733 30 Roshdy street, Roshdy, Alexandria, Egypt.
City Postal code Country Position/Affiliation
Alexandria Egypt Associate professor Alexandria university
Role Name Email Phone Street address
Public Enquiries Abdelhamid Elhofi adelhamidelhofi@yahoo.com +2035229722 Elmosheer street ,Sidi Gaber,Alexandria
City Postal code Country Position/Affiliation
Alexandria Egypt associate professor Alexandria university
Role Name Email Phone Street address
Scientific Enquiries Amr Said docamro1@hotmail.com +201023532156 Bahaa eldin Ghatwary,Sidi Gaber
City Postal code Country Position/Affiliation
Alexandria Egypt lecturer Alexandria university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information