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.: PACTR201709002466296 Date of Approval: 24/07/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Air bubl in Vitrectomy
Official scientific title Air Bubble Technique for Fundus Visualization during Vitrectomy in 1 Aphakia
Brief summary describing the background and objectives of the trial The vitrectomy viewing systems had been improved markedly in the last 2 years.The 5 wide-angle viewing systems are divided into two types. One is the contact type 6 which uses a contact lens and the other is the noncontact type. In the contact 7 type, a contact lens is fixed on the cornea and the visibility abruptly worsens 8 when the eye ball is tilted during surgery which is not a problem in the 9 noncontact type.In 21 1989, Asfour et al, described a simplified technique for fundus visualization 22 during vitrectomy in aphakia. They provided a clear view of the fundus during 23 surgery simply by injecting a small air bubble that fills one-half to two-thirds of 24 the anterior chamber. The objective of our trial is to evaluate the efficacy and safety of air bubble technique for 2 fundus visualization during vitrectomy in aphakia.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Eye Diseases,Retinal detachment, dropped nucleus, dropped IOL
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/03/2012
Actual trial start date 03/03/2012
Anticipated date of last follow up 17/09/2014
Actual Last follow-up date 24/12/2014
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 53
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 Air bubble technique in vitrectomy for phakic and indicated for phacovitrectomy intraoperative intraoperative surgical technique 7 Active-Treatment of Control Group
Experimental Group Air bubble technique in vitrectomy for aphakia intraoperative intraoperative surgical technique 22
Experimental Group Air bubble technique in unplanned vitrectomy for immediate phacoemulsification complication intraoperative intraoperative surgical technique 24
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- phakic eyes needing combined phacoemulsification and PPV 2-aphakic eyes needing PPV 3-unplanned PPV for immediate management of a phacoemulsification surgery complicated by rupture posterior capsule with dropped nucleus, fragments or IOL Cases with complicated vitreoretinal pathology were not included in this study; e.g., advanced PVR & diabetic fibro-vascular membranes 25 Year(s) 89 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 25/01/2012 SOhag University, Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
Sohag University, faculty of Medicine Sohag Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Surgical success intraoperative visualization using the air buble technique
Secondary Outcome Best corrected visual acuity 6 months postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Sohag University Hospital Madinat naser Sohag 82525 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
None none Sohag 82525 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Sohag University Hospital Madinat naser Sohag 82525 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Mahmoud Mohamed Faroul sohag university, ophthalmology Deaprtment Sohag 82525 Egypt
Takeshi Naito The Department of Ophthalmology, Graduate School of Biomedical 11 Sciences, Tokushima University, 3-18-15 Kuramoto-cho Tokushima 770-8503 Japan
Mohammed Elagouz sohag university, ophthalmology Deaprtment Sohag 82525 Egypt
Hatem Ammar sohag university, ophthalmology Deaprtment Sohag 82525 Egypt
Engy Mohamed Mostafa sohag university, ophthalmology Deaprtment Sohag 82525 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mahmoud Mohamed farouk drmfaroukophth@yahoo.co.uk +2/01000400883 Sohag University, Ophthalmology deaprtment
City Postal code Country Position/Affiliation
Sohag Egypt Lecturer of ophthalmology, Sohag University
Role Name Email Phone Street address
Public Enquiries Engy M Mostafa engymostafa@yahoo.com +2/01005643587
City Postal code Country Position/Affiliation
Sohag Egypt Assistant Professor in sohag medical school
Role Name Email Phone Street address
Scientific Enquiries Mahmoud Mohamed farouk drmfaroukophth@yahoo.co.uk +2/01000400883 Sohag University, Ophthalmology deaprtment
City Postal code Country Position/Affiliation
Sohag Egypt Lecturer of ophthalmology, Sohag University
REPORTING
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