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Comparison of Outcomes and Complications of Phaco-Trabeculectomy (PT) With Phaco-Viscocanalostomy (PVC) in glaucoma patients: a single blind randomized controlled trial

Protocol summary

Study aim
Comparison of Outcomes And Complications of Phaco-Trabeculectomy (PT) With Phaco-Viscocanalostomy (PVC)
Design
A randomized, single-blind, clinical trial of 60 patients. Minim software was used for randomization.
Settings and conduct
60 people who referred to the ophthalmology clinic of Shafa Hospital in Kerman (30 participants in the PT group and 30 participants in the PVC group) will be selected based on the inclusion criteria. After obtaining informed consent, a complete eye examination including visual acuity, IOP assessment, and gonioscopy will be performed by a glaucoma specialist. After the surgery, the consequences and complications of the operation will be evaluated in the first, fourth and sixth weeks after the operation. This is a single blind study since the patient, eye surgeon and data collector should be aware of the type of surgery, but Information will be kept confidential from the statistician.
Participants/Inclusion and exclusion criteria
The study population: all glaucoma patients referred to the ophthalmology clinic that are candidates for phycoemulsification surgery (for the treatment of cataracts) + glaucoma surgery (Trabeculectomy or Viscocanalostomy).
Intervention groups
Phycoviscocanalostomy: applying two scleral flaps, exposure of the schlemm canal, injection of the hyaluronic acid gel for 5-6 times, suturing the flaps, no need for a conjunctival bleb. Phycotrabelectomy: Periotomy and separation of the conjunctiva and tenon from the sclera, removal of the scleral flap close to the limbus, placing mitomycin c under the conjunctiva and tendon for 1.5 minutes, and irrigation, removal of the scleral block by 1× 1 mm and Peripheral iridectomy, suturing the scleral flap, suturing the limbal conjunctiva
Main outcome variables
Comparison of IOP, Visual Acuity, early and late postoperative complications, and intraoperative complications in PT and PVC methods.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220116053736N1
Registration date: 2022-01-27, 1400/11/07
Registration timing: prospective

Last update: 2022-01-27, 1400/11/07
Update count: 0
Registration date
2022-01-27, 1400/11/07
Registrant information
Name
Mahdi Sharifzadeh Kermani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3211 5794
Email address
mehdisharifzade818@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-04, 1400/11/15
Expected recruitment end date
2022-09-21, 1401/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Outcomes and Complications of Phaco-Trabeculectomy (PT) With Phaco-Viscocanalostomy (PVC) in glaucoma patients: a single blind randomized controlled trial
Public title
Comparison of Outcomes and Complications of Phaco-Trabeculectomy (PT) With Phaco-Viscocanalostomy (PVC) in glaucoma patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Glaucoma of Primary Open-Angle Glaucoma (POAG), Pseudoexfoliative Glaucoma (PXG), Chronic Angle Closure Glaucoma (CACG) uncontrolled with at least 2 topical medications (0.5% thymolol drops, 2 times a day) and dorsolamide 3 times daily (IOP > 21 mm Hg). Glaucoma of Primary Open-Angle Glaucoma (POAG), Pseudoexfoliative Glaucoma (PXG), Chronic Angle Closure Glaucoma (CACG) Despite using several anti-glaucoma drugs. Significant cataract (BCVA ≤20 / 60) justified by lens opacity.
Exclusion criteria:
History of intraocular surgery such as vitreous and retinal surgery Phacomorphic glaucoma Significant corneal opacity Secondary glaucoma (Uveitis Glaucoma, neovascular glaucoma, pigmentary glaucoma) Diabetic retinopathy History of eye trauma Posterior chamber eye diseases History of phycoemulsification (PE) and glaucoma surgeries Incomplete participants' information (> 10%) Signing the written informed consent
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
To randomize the participants, minimization method was used (randomization unit: individual). The random sequence was built with Minim software. In this study the allocation concealment was carried out too.
Blinding (investigator's opinion)
Single blinded
Blinding description
The blinding method in this study will be single blind because the patient, eye surgeon (glaucoma specialist) and data collector (clinical assistant of eye diseases) must be aware of the type of surgery. But the information from the statistician will be kept secret. In this regard, the data gatherer will randomly name the intervention and control group A or B by and send the patients data to the statistician.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Haft Bagh Alavi Blvd, campus of University of Medical Sciences
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2021-12-28, 1400/10/07
Ethics committee reference number
IR.KMU.AH.REC.1400.232

Health conditions studied

1

Description of health condition studied
Glaucoma is a group of disorders that differ in their pathophysiology, risk factors, manifestations, treatments, and prognoses. Their common feature is progressive degeneration of the optic nerve, with loss of retinal ganglion cells, thinning of the retinal nerve fiber layer, and progressive excavation of the optic disc.
ICD-10 code
H44.51
ICD-10 code description
Absolute glaucoma

2

Description of health condition studied
A cataract is a cloudy area in the lens of the eye that leads to a decrease in vision. It often develop slowly and can affect one or both eyes.
ICD-10 code
H26.9
ICD-10 code description
Unspecified cataract

Primary outcomes

1

Description
Intraocular pressure (IOP)
Timepoint
At the beginning of the study (before the intervention), in the first and fourth weeks, and sixth months after surgery
Method of measurement
Goldmann tonometry

2

Description
Number of drops used to reduce IOP
Timepoint
Before intervention, 1 and 4 weeks and 6 months after intervention
Method of measurement
The designed checklist

3

Description
Intraoperative complications
Timepoint
From the beginning to the end of the surgery
Method of measurement
Examination by a glaucoma subspecialist

4

Description
Postoperative early complications
Timepoint
In 1 and 4 weeks following surgery
Method of measurement
Examination by a glaucoma subspecialist

5

Description
Postoperative late complications
Timepoint
Six months after surgery
Method of measurement
Examination by a glaucoma subspecialist

6

Description
Visual Acuity
Timepoint
Before intervention, 1 and 4 weeks and 6 months after surgery
Method of measurement
Snellen chart

Secondary outcomes

1

Description
Need to use antiglaucoma drugs after surgery
Timepoint
In the first and fourth weeks and the sixth month after surgery
Method of measurement
Examination by a glaucoma subspecialist

Intervention groups

1

Description
Intervention group: First group: The first group underwent phaco-trabeculectomy (PT) surgery, in which after phycoemulsification (PE), a limbus block measuring 1×1 mm will be removed from the scleral flap. After removal of the viscoelastic material, acetylcholine chloride 1% will be injected to create pupilary stenosis and peripheral iridectomy will be performed. Two sutures with 10-0 nylon threads on both sides tightens the scleral flap. The conjunctiva will then will be sutured to the limbus with 10-0 nylon thread.
Category
Treatment - Surgery

2

Description
Intervention group: Second group: The second group will undergo Viscocanalostomy (PVC) surgery. After phycoemulsification (PE), dissection of a 4× 4-mm triangular scleral flap underneath a 5× 5 mm superficial flap will deroof Schlemm’s canal. The inner scleral flap will be pulled upward, and the floor of the canal and Descemet’s membrane will be depressed with the tip of a cellulose sponge. The membrane was then cleaved from the cornea for a distance of about 1 mm. Afterwards, the inner scleral flap will be excised. After cannulation and assurance from correct positioning, the proximal ends of the Schlemm’s canal, as well as the intrascleral space, will be filled with sodium hyaluronate according to Stegmann’s technique.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Shafa hospital
Full name of responsible person
Mahdi Sharifzadeh Kermani
Street address
Kowsar Boulevard, Shafa Educational and Medical Center
City
Kerman
Province
Kerman
Postal code
7618751151
Phone
+98 34 3211 5780
Email
shafahospital@kmu.ac.ir
Web page address
https://sh.kmu.ac.ir/fa

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Gholamreza Sepehri
Street address
Haft Bagh Alavi Blv, campus of University of Medical Sciences
City
Kerman
Province
Kerman
Postal code
7618751151
Phone
+98 34 3325 7672
Email
gsepehri@yahoo.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Mahdi Sharifzadeh Kermani
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Shafa Blvd,Shafa Hospital,Ophthalmology Department, Kerman Town
City
Kerman
Province
Kerman
Postal code
7618751151
Phone
+98 34 3211 5794
Fax
Email
m.sharifzadeh@kmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mahdi Sharifzadeh Kermani
Position
Ophthalmologist,Assiciate professor, Faculty member of Kerman University of Medical Sciences
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Shafa Blvd, Shafa Hospital, Ophthalmology Department
City
Kerman
Province
Kerman
Postal code
7618751151
Phone
+98 34 3211 5794
Email
msharif3000@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mahdi Sharifzadeh Kermani
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Shafa Blvd,Shafa Hospital,Ophthalmology Department, Kerman Town
City
Kerman
Province
Kerman
Postal code
7618751151
Phone
+98 34 3211 5794
Fax
Email
msharif3000@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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