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.: PACTR201910823824561 Date of Approval: 11/10/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The efficacy and safety of High-Frequency Deep Sclerotomy in treatment of chronic open-angle glaucoma patients.
Official scientific title High Frequency Deep Sclerotomy; efficacy and safety
Brief summary describing the background and objectives of the trial Subscleral trabeculectomy (SST) is considered the standard technique when surgery is needed to lower intraocular pressure (IOP) in chronic open angle glaucoma patients . Nevertheless, the development of non-penetrating glaucoma surgeries, as deep sclerectomy, viscocanalostomy , and canaloplasty, have evolved to bypass the resistance in pathologic inner wall of Schlemm’s canal without entering anterior chamber leaving intact trabeculoDescemet membrane. Newer surgical techniques were introduced to overcome the transconjunctival approach and to increase the safety of glaucoma surgeries; which were collectively named Minimally Invasive Glaucoma Surgery (MIGS). Some of these procedures work via enhancing the filtration through Schlemm’s canal like Trabectome, iStent, Hydrus implant, and High Frequency Deep Sclerotomy (HFDS). Our study aims to highlight the HFDS as a competing Ab interno surgery in open angle glaucoma patients. Evaluate the efficacy of high frequency deep Sclerotomy in lowering IOP of chronic open angle glaucoma patients, in addition to the evaluation of the safety of the procedure on corneal endothelium.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) HFDS
Disease(s) or condition(s) being studied Eye Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 02/07/2016
Actual trial start date 02/07/2016
Anticipated date of last follow up 22/11/2018
Actual Last follow-up date 29/12/2018
Anticipated target sample size (number of participants) 43
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL www.oertli-instruments.com/.../new_minimally_invasive_deep_ sclerotomy_ab_interno_surgical_procedure_for_glaucoma_six_yea...
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 Randomised Simple randomization using a randomization table from a statistics book Central randomisation by phone/fax Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Surgical treatment of open angle glaucoma HFDS Single procedure Half an hour and follow up for nine months The procedure was done with the Abee® Glaucoma Tip of Oertli phacoemulsification machine (OS3, Switzerland) and goniolens performing nasal six pockets penetrating 1mm deep into trabecular meshwork and Schlemm’s canal. 43
Control Group usual hypotensive medical treatment Three types of Eye drops twice per day For one month Beta Blocker eye drops. Carbonic anhydrase inhibitor eye drops. Alpha agonist eye drops 43 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
chronic open angle glaucoma resistant to medical treatment progression of field uncontrolled intraocular pressure Previous glaucoma surgery Neovascular glaucoma Congenital glaucoma Uveitic glaucoma Traumatic glaucoma Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 35 Year(s) 75 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 23/02/2016 Research Institute of Ophthalmology
Ethics Committee Address
Street address City Postal code Country
2 Al Ahram Street Cairo 12557 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Target intraocular pressure less than 21 mmHg in chronic open angle glaucoma patients. Prevent progression of field changes. First week, second week, first month, second month, third month, sixth month, ninth month
Secondary Outcome Protection of corneal endothelium after procedure by specular microscopy measuring mean central Endothelial cell count and coefficient of variation Ninth month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Research Institute of Ophthalmology Al Ahram Street, Giza Cairo 12511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Prof. Ayman El Shiaty 1 Saray Al Manial Cairo 11562 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mokhtar Mohamed Ebraheem Al Ahram Street, Giza Cairo 12511 Egypt Institute of Ophthalmology
COLLABORATORS
Name Street address City Postal code Country
Shaymaa Hassan Salah 1 Saray Al Manial street Cairo 11562 Egypt
Ayman El Shiaty 1 Saray Al Manial Street Cairo 11562 Egypt
Tarek El Beltagi 1 Al Ahram Street, Giza Cairo 12511 Egypt
Mokhtar Mohamed Ebraheem 1 Al Ahram Street, Giza Cairo 12511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Shaymaa Hassan Salah shaimaa.sayed@kasralainy.edu.eg +201002229645 1 Saray Al Manial
City Postal code Country Position/Affiliation
Cairo 11562 Egypt Kasr Alainy Hospital Cairo University
Role Name Email Phone Street address
Principal Investigator Mokhtar Mohamed Ebraheem mokh211@yahoo.com +201143125392 1 Al Ahram Street
City Postal code Country Position/Affiliation
Cairo 12562 Egypt Research Institute of Ophthalmology
Role Name Email Phone Street address
Public Enquiries Tarek El Beltagi tarekelbeltagi@gmail.com +201002229645 Al Ahram Street
City Postal code Country Position/Affiliation
Cairo 12562 Egypt Research Institute of Ophthalmology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD that underlie the results reported in this article after deidentification (text, tables, figures) Study Protocol Immediately following publication. No end date. Controlled: Researchers who provide a methodologically sound proposal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes The mean preoperative IOP was 31.4 +/- 4.71 mmHg (range: 22 to 42 mmHg) on medical hypotensive drops. All patients were followed up for nine months. The mean IOP was 19.06 +/- 1.907 mmHg (range: 15 to 26 mmHg) by the end of the study. The reduction across the follow-ups was statistically significant (P<0.0001). The percentage of total success was 90.7% (39 eyes). Four eyes (9.3%) had IOP > 21(failed) after surgery and continued on antiglaucoma therapy. 10/10/2019 03/02/2020
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks scholar.cu.edu.eg/?q=shaymaahassansalah/content/my-cv-48
Changes to trial information