Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202508908830998 Date of Registration: 07/08/2025
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title YAG Laser Peripheral Iridotomy in Primary Angle Closure
Official scientific title Impact of YAG Laser Peripheral Iridotomy on Anterior Segment in Primary Angle Closure using Optical Coherence Tomography and Corneal Tomography
Brief summary describing the background and objectives of the trial Glaucoma is a major cause of irreversible blindness worldwide, with primary angle closure glaucoma (PACG) accounting for 25% of all kinds of glaucoma globally. The angle closure spectrum includes three stages; primary angle-closure suspects (PACS), primary angle closure (PAC), and primary angle closure glaucoma (PACG). Several studies have proven that patients with PACS as well as PAC can benefit from laser peripheral iridotomy (LPI) in relieving pupillary block, widening the AC angle, and decreasing the risk of progression into PACG. Gonioscopy is the golden standard for angle examination in those patients, however has some disadvantages, which may significantly affect the precise record of angle width; including patient’s eye contact and use of light that may affect the angle opening. In addition, the procedure can take years to master, and can be subjective with no agreement between the examiners . The introduction of new imaging modalities such as corneal tomography and anterior segment optical coherence tomography (AS-OCT) can have some advantages over gonioscopy such as providing accurate, reliable and reproducible measurement of different AC parameters, requiring no contact with the eye and the ability to be done in complete darkness or under standardized lighting conditions. Aim of the work: To evaluate changes in anterior segment parameters before and after LPI in patients with PACS and PAC using AS-OCT and corneal tomography. Objectives: 1) Measure and compare changes in AC parameters in patients with PACS and PAC before, one month and 3 months after LPI using both AS-OCT and corneal tomography. 2) Correlate between the AC parameters measured by AS-OCT, corneal tomography and gonioscopy. 3) Report changes in intraocular pressure at one month and 3 months after LPI in patients with PACS and PAC. 4) Report any complications related to the intervention.
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 04/08/2024
Actual trial start date 06/08/2024
Anticipated date of last follow up 09/08/2025
Actual Last follow-up date 09/08/2025
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
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 Sequence/Code was not concealed Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Laser Peripheral Iridotomy a single treatment session using Nd:YAG laser until full thickness perforation of the iris. followed by 3 months of follow up initially patients clinical examination, together with baseline anterior chamber angle examination was done using gonioscopy, AS-OCT and corneal tomography. the included patients were subjected to Laser peripheral iridotomy (LPI) as follow. Patients received pilocarpine 1% eye drops as well as one drop of brimonidine tartrate 0.15% one hour before the intervention. The neodymium-doped yttrium aluminum garnet (Nd:YAG) laser, which rely on tissue photo-disruption to create a rapidly expanding ionic plasma wave and thus is efficient in all iris colors, was used with a single to three pulses starting with 5 (mJ) power and spot size of 50 (μm) at an iris crypt between one and eleven o'clock position of the peripheral iris and repeated until patency is achieved. The defocus is set to zero with the focus of the beam directed on iris stroma rather than iris surface. Whole thickness perforation of the iris is assumed when pigment, mixed with aqueous, flows from the posterior into the anterior chamber and the ophthalmologist assessed the patency by direct visualization of the posterior chamber through retro-illumination technique. follow-up at one and three months with reassessment of anterior chamber angle using gonioscopy, AS-OCT and corneal tomography. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patient aged > 40 years fulfilling the criteria of PACS or PAC: primary angle closure suspect (PACS): characterized by narrow angles by gonioscopy (at least 180°of trabecular meshwork is invisible), but without IOP elevation, glaucomatous damage of the optic nerve, or visual field changes. Primary angle closure (PAC): having the same previous criteria but with elevated IOP and/or peripheral anterior synechia. 1) Patients with history of previous ocular or refractive surgery, ocular injury, or laser procedure. 2) Patients with concurrent ocular pathology as cataract, diabetic retinopathy, dense corneal opacity, other posterior segment pathology or secondary glaucoma. 3) Patients with chronic angle closure with history of recurrent attacks of acute angle closure with extensive PAS that necessitates surgical intervention. 4) Patients with severe systemic disease and unable to tolerate LPI treatment such as tremors, heart and liver diseases. 5) Patients unable to cooperate for the examination, or unsuitable for gonioscopy like severe uveitis. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 40 Year(s) 70 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 04/08/2024 Zagazig university Faculty of medicine institutional review board
Ethics Committee Address
Street address City Postal code Country
Rd inside Zagazig University, Shaibet an Nakareyah, Zagazig, Ash Sharqia Governorate Zagazig 44519 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Measure and compare changes in the anterior chamber parameters in patients with primary angle closure suspect and primary angle closure before and after laser peripheral iridotomy using gonioscopic examination, AS-OCT, and corneal tomography. after one and three months of Laser peripheral iridotomy
Secondary Outcome 1- Correlate between the anterior chamber parameters measured by AS-OCT, corneal tomography and gonioscopy. 2- Report changes in intraocular pressure one month and 3 months after LPI in patients with PACS and PAC. 3- Report any complications related to the intervention. after one and three months of Laser peripheral iridotomy
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Zagazig University Hospital Koliat Al Tob St, Shaibet an Nakareyah, Markaz El-Zakazik, Ash Sharqia Governorate Zagazig 44519 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Zagazig University shaibet an Nakareyah, zagazig Zagazig 44519 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Zagazig University shaibet an Nakareyah, zagazig Zagazig 44519 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ahmed Mohamed Elsayed Lotfy Alqawmia square Zagazig 44519 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Mohamed Elsayed Lotfy lotfyahmed299@gmail.com +201151740408 Alqawmia square
City Postal code Country Position/Affiliation
Zagazig 44519 Egypt Ophthalmology resident
Role Name Email Phone Street address
Scientific Enquiries Tarek Elbromboly elbromboly@hotmail.com +201001748726 Alqawmia square
City Postal code Country Position/Affiliation
Zagazig 44519 Egypt professor of ophthalmology
Role Name Email Phone Street address
Public Enquiries Marwa Khairy marwakhairy@medicine.zu.edu.eg +201111801956 Alqawmia square
City Postal code Country Position/Affiliation
Zagazig 44519 Egypt lecturer of ophthalmology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD underlying the results (texts, tables, figures and appendices)will be available after deidentification and will be available for data metanalysis Statistical Analysis Plan,Study Protocol Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA)
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
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 07/08/2025 PACTR Admin Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s) Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s)