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Comparison of results and complications of Phacoviscocanalostomy surgery with and without implants in patients with open angle glaucoma

Protocol summary

Study aim
Evaluation of the results and complications of 6-month Phacoviscocanalostomy with and without implants in patients with glaucoma
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, without instance of the trial phase on 60 patients. By simple randomization method, the subjects are divided into two groups of 30 intervention and control.
Settings and conduct
In this study, which is performed by clinical trial method, 60 patients with open-angle glaucoma referred to the ophthalmology clinic of Khatam-al-Anbia Hospital and with admission criteria by simple randomization method are divided into two groups that one group In addition to Viscocanalostomy,also subjected to intrascleral implantation using the remnants of Ahmed valve’s tube.In the first three follow-ups, intraocular pressure(IOP), best corrected visual aquity(BCVA )and the number of drugs and in the sixth month follow-up, in addition to these cases, anterior segment optimal coherence tomography(AS OCT )is performed to check the area of the bleb.In this study, the subjects will not be aware of the use or non-use of implants and analysts will not be aware of patients' exposure or control. After collecting the data, we enter them into SPSS version 24 software and analyze them according to the objectives
Participants/Inclusion and exclusion criteria
Patient Satisfaction - Open Angle Glaucoma - Indication of Glaucoma Surgery - No Previous Surgery
Intervention groups
In this study, in the control group, only Viscocanalostomy was performed and in the intervention group, in addition to Viscocanalostomy, they underwent intrascleral implantation using the remnants of Ahmed valve’s tube.
Main outcome variables
Preservation of intrascleral bleb; Improved fluid flow to suprachroidal flow; Implant availability

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200704047997N1
Registration date: 2020-11-08, 1399/08/18
Registration timing: retrospective

Last update: 2020-11-08, 1399/08/18
Update count: 0
Registration date
2020-11-08, 1399/08/18
Registrant information
Name
Ali Bagheri Asl
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3728 9911
Email address
ali.bagheri7181@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-05, 1399/05/15
Expected recruitment end date
2020-09-05, 1399/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of results and complications of Phacoviscocanalostomy surgery with and without implants in patients with open angle glaucoma
Public title
Comparison of results and complications of Phacoviscocanalostomy surgery with and without implants in patients with open angle glaucoma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient satisfaction Open angle glaoucoma Indication of glaucoma surgery No previous surgery (glaucoma surgeries)
Exclusion criteria:
Complications during surgery Impossibility to follow up Lack of patient cooperation during follow-up
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization method The envelope method will be used for random assignment of patients in study groups. In this way, random numbers will be prepared with the help of randomize.com and will be placed in sealed envelopes. The lid of the envelope is closed and the contents of the envelope will not be visible from the outside. The secretary of the clinic will deliver one of the envelopes to the patient and the surgeon will study the patient in one of the two groups based on the contents of the envelope.
Blinding (investigator's opinion)
Double blinded
Blinding description
Analysts will not know if patients are exposed or controlled. Subjects will not be aware of their exposure or control.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Aboutaleb Crossroads, Khatam Al-Anbia Ophthalmology Hospital
City
mashhad
Province
Razavi Khorasan
Postal code
9195965919
Approval date
2019-12-18, 1398/09/27
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1398.672

Health conditions studied

1

Description of health condition studied
Open angle glaoucoma
ICD-10 code
H40.1
ICD-10 code description
Open-angle glaucoma

Primary outcomes

1

Description
Bleb area measurement
Timepoint
Six months after surgery
Method of measurement
By anterior segment OCT

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In this group, in addition to Phacoviscocanalostomy, they undergo intrascleral implants.In this intervention, a part of the Ahmed valve tube, which remains from the previous AGV operation and is practically useless, is sterilized and divided into two parts and the end 4 mm is cut. This tube is placed in the suprachroidal space.
Category
Treatment - Devices

2

Description
Control group: In this group, only Phacoviscocanalostomy is performed and no implant is used.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Khatam Al-Anbia Ophthalmology Hospital
Full name of responsible person
Ali Bagheri Asl
Street address
Aboutaleb Crossroads, Khatam Al-Anbia Ophthalmology Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Phone
+98 51 3728 1401
Fax
Email
ali.bagheri7181@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
next to Hoa,veyzeh Cinem Ghorashi Building, Deputy of Research and Technology
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
Tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ali Bagheri Asl
Position
Resident of ophthalmology
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Khatam-Al-Anbia Eye Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Phone
+98 51 3728 9911
Fax
Email
ali.bagheri7181@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ali Bagheri Asl
Position
Ophthalmology resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Aboutaleb Crossroads, Khatam Al-Anbia Ophthalmology Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Phone
+98 51 3728 1401
Email
ali.bagheri7181@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ali Bagheri Asl
Position
Ophthalmology resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Aboutaleb Crossroads, Khatam Al-Anbia Ophthalmology Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Phone
+98 24 3377 8680
Email
ali.bagheri7181@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
All data can be shared
When the data will become available and for how long
Access period starts 3 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
-
From where data/document is obtainable
Ali Bagheri Asl ali.bagheri7181@gmail.com
What processes are involved for a request to access data/document
Send the request via email and state the reason for the request
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