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.: PACTR202407919141324 Date of Approval: 22/07/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Assessment of Retinal Microvascular Alterations After YAG Laser Capsulotomy Using Optical Coherence Tomography Angiography
Official scientific title Assessment of Retinal Microvascular Alterations After YAG Laser Capsulotomy Using Optical Coherence Tomography Angiography
Brief summary describing the background and objectives of the trial Background: Following a straightforward cataract operation, posterior capsular opacification (PCO), commonly referred to as "secondary cataract" or "after cataract," appears over the clear posterior capsule a few months to a few years later. Objectives: To evaluate the effect of Neodymium-doped Yttrium Aluminum-Garnet (Nd: YAG) laser capsulotomy on retinal microvasculature by comparing it before and after Nd-YAG laser capsulotomy using optical coherence tomography angiography.
Type of trial Non-Randomised
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 Diagnosis / Prognosis
Anticipated trial start date 05/07/2024
Actual trial start date
Anticipated date of last follow up 10/08/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 35
Actual target sample size (number of participants)
Recruitment status Active, not 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
Single Group Non-randomised Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group YAG laser Capsulotomy approximately 20 minutes YAG laser Capsulotomy is a laser treatment applied on the capsule that supports the artificial lens in the eye after cataract surgery. During cataract surgery, the natural lens inside your eye is removed from the lens capsule and an artificial lens is put in its place. With time, the lens capsule can become cloudy which prevents light from reaching the back of the eye (retina). The laser beam is used to make a small opening into the cloudy capsule to allow the light to pass through, allowing you to see more clearly. 35
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Following straightforward cataract surgery with posterior chamber intraocular lens implantation, patients with unilateral or bilateral visually significant PCO 2. Reasonable fundal view on non-contact lens fundoscopy 3. The recovery period following cataract surgery was at least six months. 4. Age group : 40-80 5. Both sex. 6. Non Diabetic 1. Current ocular pathology e.g. Corneal opacities, glaucoma, retinopathy, maculopathy, optic neuropathy. 2. Previous history of treated macular disease e.g. CME after cataract surgery. 3. Diabetes mellitus. 4. Systemic vascular disease. 5. Prior eye surgery other than a cataract procedure 80 and over: 80+ Year,Aged: 65+ Year(s) 40 Year(s) 80 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 01/08/2023 Faculty Of Medicine Port Said University
Ethics Committee Address
Street address City Postal code Country
23 December st , Alzohur, Port Said, Egypt egypt 42511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To compare retinal microvascular changes in patients with posterior capsular opacification (PCO) before and after cataract Nd-YAG laser capsulotomy . one month after YAG laser
Secondary Outcome Intraocular presser and Best corrected visual acuity one month after YAG laser
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Portsaid Ophthalmolgy hospital 23 July st Port said Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Osama Abdelgalil Abokahla 75 Shaaban El behiry El Mehalla El Kubra 31951 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Osama Abd Elgalil Abokahla 75 shaaban el behiry st El Mehalla El Kubra 31951 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Ehab Mahmoud Ghoneim Por foad Port Said 42511 Egypt
Mohamed Mounir Mohamed Esraa discrit Ismailia 41511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Osama Abokahla abokahla50@gmail.com +201288759391 75 shaaban el behiry st
City Postal code Country Position/Affiliation
El mehalla El kubra 31951 Egypt Resident of ophthalmology
Role Name Email Phone Street address
Public Enquiries Osama Abokahla abokahla50@gmail.com +201288759391 75 shaaban el behiry st
City Postal code Country Position/Affiliation
El mehalla El kubra 31951 Egypt Resident of ophthalmology
Role Name Email Phone Street address
Scientific Enquiries Osama Abokahla abokahla50@gmail.com +201288759391 75 shaaban el behiry st
City Postal code Country Position/Affiliation
El mehalla El kubra 31951 Egypt Resident of ophthalmology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication, No end date Objectives Methodology Results
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