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.: PACTR201804003056259 Date of Approval: 06/02/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Phacoemulsifiction cataract surgery in diabetics versus non Diabetics
Official scientific title Outcomes of phacoemulsificstion cataract surgery in diabetics versus non Diabetic patients
Brief summary describing the background and objectives of the trial to compare outcomes of uncomplicated phacoemulsificstion cataract surgery as regard corneal endothelium, VA,Iop,retinal changes between diabetics and non diabetics
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cataract., Diabetes,Eye Diseases,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/04/2018
Actual trial start date 01/04/2018
Anticipated date of last follow up 01/04/2019
Actual Last follow-up date 01/04/2019
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
Recruitment status 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
Crossover: all participants receive all interventions in different sequence 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 Phacoemulsifiction cataract surgery In diabetic patient One time Phacoemulsificstion cataract surgery in diabetics patients 25
Control Group Phacoemulsifiction cataract surgery in non diabetic patients One time Phacoemulsificstion cataract surgery in non diabetics patients 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Diabetics with good glycerin control Age:50-75 Non diabetics control group Corneal Pathology Non dilated pupil Glaucoma patients Diabetics with pre-existing macula Pathology Diabetics with severe Diabetic retinopathy 45 Year(s) 75 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 09/12/2017 Faculty of Medicine of sohag University
Ethics Committee Address
Street address City Postal code Country
Eastern bank of nile Sohag Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Corneal endothelial changes 1week 1 month 6 month
Primary Outcome Incidence of pco 1month 3 months 6 months
Primary Outcome Incidence of post operative macula edema 3months 6 months
Secondary Outcome Post operative visual acuity 1week 1month 3 months 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Sohag University sohag,eastern bank of nile Sohag Egypt
Sohag University hospital El-khouly,Qesm Away,Sohag Governorate Sohag Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Sohag University hospital sohag,eastern bank of nile Sohag Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Sohag University hospital sohag,eastern bank of nile Sohag Egypt Hospital
Primary Sponsor Sohag university sohag,eastern bank of nile Sohag Egypt University
COLLABORATORS
Name Street address City Postal code Country
Sohag University hospital sohag,eastern bank of nile Sohag Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Alaa Mahmoud alaamahmoud13102011@gmail.com 01060422011 sohag University hospital, El_Khouly,Qesm Away sohag
City Postal code Country Position/Affiliation
Sohag Egypt Assistant lecturer
Role Name Email Phone Street address
Public Enquiries Mortada Ahmed Abozaid mortada_abdelaal@med.sohag.edu.eg 0120 332 4446 sohag University hospital, El_Khouly,Qesm Away sohag
City Postal code Country Position/Affiliation
Sohag Egypt assistant professor
Role Name Email Phone Street address
Scientific Enquiries Mohamed Iqbal dr_m_iqbal@yahoo.com 01068559840 sohag University hospital, El_Khouly,Qesm Away sohag
City Postal code Country Position/Affiliation
Sohag Egypt assistant professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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