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.: PACTR202306612520344 Date of Approval: 20/06/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A Comparative Assessment of Ocular Prostheses Motility in Atrophia Bulbi Versus Implanted Anophthalmic Sockets (A Randomized Controlled Clinical Trial)
Official scientific title A Comparative Assessment of Ocular Prostheses Motility in Atrophia Bulbi Versus Implanted Anophthalmic Sockets (A Randomized Controlled Clinical Trial)
Brief summary describing the background and objectives of the trial Loss of an eye caused by cancer, trauma, or congenital defect creates a deep psychological impact on an individual’s life especially social and professional life. There are two types of ocular prosthesis available: Ready-made or “stock: shells, which are readily available, inexpensive and can be fitted instantly; and customized prosthesis, which are tailored and customized to the individual user. Customization is an important aspect of prosthetic rehabilitation which brings the cosmetic appearance to near normal levels, provides a better fit to the eye socket, and less discomfort to the patient in the long term. The aim of this study is to compare the relationship between customized and ready-made ocular prostheses thickness and size and their motility in patients with either atrophia bulbi or implanted anophthalmic sockets.
Type of trial RCT
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: Devices
Anticipated trial start date 31/05/2023
Actual trial start date
Anticipated date of last follow up 31/12/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL N/A
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 Randomised Permuted block randomization Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Customized Atrophia N/A Once accurate impression, wax model Position of the iris will be determined then painted and Ocular prosthesis will be processed into heat polymerizing PMMA then delivered to the patient. 10
Control Group Ready made Atrophia N/A Once Stock ocular prostheses of suitable size and color will be selected and reduced in size if needed then then delivered to the patient. 10 Active-Treatment of Control Group
Experimental Group Customized Implanted N/A Once accurate impression, wax model Position of the iris will be determined then painted and Ocular prosthesis will be processed into heat polymerizing PMMA then delivered to the patient. 10
Control Group Ready made Implanted N/A Once Stock ocular prostheses of suitable size and color will be selected and reduced in size if needed then then delivered to the patient. 10 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patient with unilateral missing eye with either atrophia bulbi or implanted anopthalamic socket. Have enough ocular bed to accommodate the ocular prosthesis. At least 15 days after surgery to allow complete healing of the socket. Patients under steroid therapy or those under radio or chemotherapy. Patients having eye lid deformity. History of psychological disorder. systemic disease. eye infection Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 65 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 26/02/2023 The Ethics Committee of the Faculty of Dentisry Alexandria University IRB NO 00010556 IORG 0008839
Ethics Committee Address
Street address City Postal code Country
Champollion St., El Messalah, Azarita Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Ocular motility After 24 hours of insertion, and three months postoperatively.
Secondary Outcome Patient satisfaction score Three months postoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Outpatient Clinic of Department of Prosthodontics Faculty of Dentistry Alexandria University Champollion St., El Messalah, Azarita Alexandria 21521 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mervat El Sayed AbdELLAH Champollion St., El Messalah, Azarita Alexandria 21521 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Prosthodontics Faculty of Dentistry Alexandria University Champollion St., El Messalah, Azarita Alexandria 21521 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mervat El Sayed AbdELLAH Champollion St., El Messalah, Azarita Alexandria 21521 Egypt
Mohamed Moataz Khamis Abdel Razek Champollion St., El Messalah, Azarita Alexandria 21521 Egypt
Akram Fathy Neena Champollion St., El Messalah, Azarita Alexandria 21521 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
Role Name Email Phone Street address
Principal Investigator Mervat AbdELLAH Mirvat.abdella@alexu.edu.eg 00201283803657 Champollion St., El Messalah, Azarita
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Lecturer of Prosthodontics Faculty of Dentistry Alexandria University Egypt
Role Name Email Phone Street address
Scientific Enquiries Mohamed Abdel Razek moataz_khamis@yahoo.com 00201001634254 Champollion St., El Messalah, Azarita
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Professor of Prosthodontics Faculty of Dentistry Alexandria University Egypt
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data that will be collected during the trial, after deidentification. Informed Consent Form,Study Protocol Immediately following publication. No end date. To get the data please send an e-mail to elsayedamr@yahoo.com
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A 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