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.: PACTR202303599487772 Date of Registration: 29/03/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Real-world results of Zeiss selective laser trabeculoplasty in South African adult glaucoma and ocular hypertension patients.
Official scientific title Real-world results of Zeiss selective laser trabeculoplasty in South African adult glaucoma and ocular hypertension patients.
Brief summary describing the background and objectives of the trial Aim: To investigate the safety and efficacy of the ZEISS SLT laser in treating open angle glaucoma and ocular hypertension in a real-world clinical practice. Selective laser trabeculoplasty (SLT) has been used as an alternative or supplementary treatment to conventional glaucoma therapy for almost 20 years. The majority of trials done on SLT compared the procedure with medical measures to lower intra-ocular pressure (IOP). This was done either in treatment naïve patients, or in patients who had their medical therapy terminated with a washout period prior to the laser. Very little is published on the effect of SLT patients who are currently on medical treatment, with the aim to decrease their medication load. The purpose of this retrospective study is to evaluate the efficacy and safety profile of the Zeiss SLT laser in glaucoma and ocular hypertension patients who are currently treated with pharmacotherapy. We will aim to prove that following SLT laser, we can decrease the number of IOP lowering agents while maintaining good IOP control in those patients who were well controlled prior to the procedure. Furthermore, in patients who do not meet their target IOP prior to SLT, we aim to establish if the procedure managed to improve their IOP control. Clinical records of all patients who had the SLT procedure between 1 May 2022 to 31 December 2022 will be examined for eligibility to the trial, whereafter data will be collected, analyzed and published.
Type of trial CCT
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 01/05/2023
Actual trial start date 01/04/2023
Anticipated date of last follow up 31/05/2023
Actual Last follow-up date 31/05/2023
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants)
Recruitment status Not yet 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 Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group SELECTIVE LASER TRABECULOPLASTY WITH ZEISS SLT LASER ONCE OFF TREATEMENT PERFORMED IN PATIENTS WHO ARE WELL CONTROLLED ON THEIR CURRENT GLAUCOMA TREATMENT FOLLOW UP AT 3 AND 6 MONTHS Selective Laser Trabeculoplasty (SLT) is performed as an out-patient procedure. A gonioscopic lens is placed on the eye to visualize the trabecular meshwork. A hundred applications of laser is administered over 360 degrees. The procedure is a safe, cost effective and efficient treatment for patients with glaucoma and ocular hypertension. 75
Experimental Group SELECTIVE LASER TRABECULOPLASTY WITH ZEISS SLT LASER ONCE OFF TREATMENT PERFORMED IN PATIETS WHO WERE NOT WELL CONTROLLED ON THEIR GLAUCOMA TREATMENT REVIEWED AT 3 AND 6 MONTHS Selective Laser Trabeculoplasty (SLT) is performed as an out-patient procedure. A gonioscopic lens is placed on the eye to visualize the trabecular meshwork. A hundred applications of laser is administered over 360 degrees. The procedure is a safe, cost effective and efficient treatment for patients with glaucoma and ocular hypertension. 75
Control Group SELECTIVE LASER TRABECULOPLASTY WITH ZEISS SLT LASER ONCE OF TREATMENT IN PATIENTS WHO ARE NOT ON ANY IOP LOWERING TREATMENT REVIEWED AT 3 AND 6 MONTHS Selective Laser Trabeculoplasty (SLT) is performed as an out-patient procedure. A gonioscopic lens is placed on the eye to visualize the trabecular meshwork. A hundred applications of laser is administered over 360 degrees. The procedure is a safe, cost effective and efficient treatment for patients with glaucoma and ocular hypertension. 50 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients with primary open angle glaucoma or ocular hypertension. Patients who had the SLT procedure in the period from May to December 2022 Must have at least 3 months follow up after SLT. Patients who are on one or more topical intraocular pressure (IOP) lowering agent prior to SLT treatment, or treatment naïve patients who received SLT as primary intervention prior to commencing IOP treatment. Patients who did not attend at least a 3-month follow-up after SLT. Patients with poorly controlled glaucoma who required surgery as primary intervention at the time of assessment, even though they may have still received SLT. Patients who had any ocular surgery during the period of the chart review. Previous successful or failed glaucoma surgery performed less than a year before the SLT procedure. Patients who had previous SLT laser. Abnormal angle anatomy that may have a degree of combined open and closed angle glaucoma. Anterior chamber angle Schaffer grade 1 or 2. Congenital glaucoma, neovascular glaucoma or uveitic glaucoma. Patients under the age of 18. Pregnancy. 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 100 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 03/05/2023 PharmaEthics REC
Ethics Committee Address
Street address City Postal code Country
Centurion Theatre Building, 123 Amkor road, Lyttleton Manor, centurion Centurion 0156 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Primary 1: To investigate whether ZEISS SLT decreased the number of IOP lowering agents required at 3, and 6 months after procedure, in glaucoma patients who are well controlled with medical therapy. (Subset A) 2: To describe the proportion of patients whose IOP reduced by >20% at 3 and 6 months after ZEISS SLT laser, in those patients who did not meet their target IOP on current medical treatment. (Subset B) 3: To estimate by how much the ZEISS SLT can reduce the IOP at 3 and 6 months after the procedure compared to baseline in those patients who did not meet their target IOP on current medical treatment. (Subset B) 4: To describe the proportion of patients whose IOP reduced by >20% at 3 and 6 months after ZEISS SLT laser, in newly diagnosed and treatment naïve glaucoma patients. (Subset C) 5: To estimate by how much the IOP was reduced at 3 and 6 months after ZEISS SLT laser compared to baseline, in newly diagnosed and treatment naïve glaucoma patients. (Subset C) at 3 and 6 months after procedure
Secondary Outcome Secondary: 6: To describe the safety of the ZEISS SLT and any complications which may have occurred following the procedure. 7: To determine if there are any pre-procedural factors that may predict the efficacy of the SLT laser (e.g. demographics, anterior chamber angle characteristics, previous surgery or baseline IOP) at 3 and 6 months after the procedure
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Dr B Church and P Wassermann private practice Netcare Umhlanga medical Center, 319 Umhlanga Rock Drive, Umhlanga, 4320 Umhlanga 4320 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Carl Zeiss Meditec Inc 5300 Central PKway, Dublin, CA, 94568 Dublin 94568 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor not applicable not applicable not applicable 1045 South Africa not applicable
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Brian Church drbrianchurch@gmail.com +27842081150 Suite 105, Netcare Umhlanga medical Center, 319 Umhlanga rocks drive,
City Postal code Country Position/Affiliation
Umhlanga 4320 South Africa Specialist ophthalmologist
Role Name Email Phone Street address
Public Enquiries Brian Church drbrianchurch@gmail.com +27842081150 Suite 105, Netcare Umhlanga Medical Center, 319 Umhlanga Rocks drive, Umhlanga Rocks
City Postal code Country Position/Affiliation
Durban 4320 South Africa Specialist Ophthalmologist
Role Name Email Phone Street address
Scientific Enquiries Brian Church drbrianchurch@gmail.com +27842081150 Suite 105, Netcare Umhlanga Medical Center, 319 Umhlanga Rocks drive, Umhlanga Rocks
City Postal code Country Position/Affiliation
Durban 4320 South Africa Specialist ophthalmologist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes No personal information of patients will be disclosed. To comply with the Protection of Personal Information Act (POPIA) and ensure data protection, only de-identified datasets will be stored on an access-controlled cloud storage to which only the principal investigator has access. To ensure anonymity, a separate sheet where the de-identified data can be linked to the patient’s clinic number will be kept solely by the principal investigator, up until data collection has been completed, and destroyed thereafter. These measures will ensure that no personal data are attributed to an identified or identifiable natural person. All results will be made publicly available and will be published, whether the findings are positive, negative, or inconclusive. The principal investigator will be accountable for the accuracy and the completeness of these reports in line with ethical reporting. Clinical Study Report,Study Protocol within 12 months of completion of study Open access
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