Protocol summary
-
Study aim
-
Investigation of anterior segment morphological changes using anterior segment optical coherence tomography in patients with coexisting primary angle closure glaucoma and cataract, undergoing either phacoemulsification or phacotrabeculectomy.
-
Design
-
Two-arm, parallel groups randomized clinical trial. The observer was masked to the study group; however, the participants were not blinded. Randomization was done with random-digit table.
-
Settings and conduct
-
Consecutive, eligible patients, consented to participate in the study in Glaucoma Clinic, Khatam Eye Hospital, Mashhad University of Medical Sciences, enters the study and randomly allocate to the study groups. Outcome measures are evaluated at postoperative 1 week, 1 month and 6 months intervals.
-
Participants/Inclusion and exclusion criteria
-
Patients with coexisting primary angle closure glaucoma and cataract, requiring surgical intervention, and without a history of previous intraocular surgery or other ocular diseases.
-
Intervention groups
-
Group A, Phacoemulsification. In this group, patient undergo standard phacoemulsification cataract surgery with foldable intraocular lens implantation.
Group B, Phacotrabeculectomy. In this group, patients undergo phacoemulsification cataract surgery and foldable intraocular lens implantation with concurrent fornix based trabeculectomy with releasable sutures and intraoperative mitomycin-C application.
-
Main outcome variables
-
1. Intraocular pressure
2. Angel opening distance
3. Trabecular iris surface area
4. Trabecular iris angle
General information
-
Reason for update
-
There are typos in entering the trial recruitment's start and end dates. Recruitment was started after approval by the Ethical Committee.
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20080901001154N2
Registration date:
2020-10-07, 1399/07/16
Registration timing:
retrospective
Last update:
2021-05-19, 1400/02/29
Update count:
1
-
Registration date
-
2020-10-07, 1399/07/16
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2015-06-20, 1394/03/30
-
Expected recruitment end date
-
2016-12-19, 1395/09/29
-
Actual recruitment start date
-
2015-08-21, 1394/05/30
-
Actual recruitment end date
-
2017-02-01, 1395/11/13
-
Trial completion date
-
2017-03-03, 1395/12/13
-
Scientific title
-
Comparison of anterior segment morphological changes using anterior segment optical coherence tomography (ASOCT) in patients with coexisting primary angle closure glaucoma and cataract, undergoing phacoemulsification and phacotrabeculectomy.
-
Public title
-
Anterior segment parameters following surgical management in angle closure glaucoma
-
Purpose
-
Treatment
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Primary angle closure glaucoma
Cataract
Exclusion criteria:
Any previous intraocular surgery (except laser iridotomy)
History of ocular trauma
History of other ocular diseases (except cataract and glaucoma)
-
Age
-
From 40 years old
-
Gender
-
Both
-
Phase
-
N/A
-
Groups that have been masked
-
No information
-
Sample size
-
Target sample size:
60
Actual sample size reached:
52
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
Envelops, containing random numbers were prepared and sealed. ،To pick the number, the first number was selected by a pen with closed eyes and then successive numbers were selected from the table (eg, if the first number was 7, we moved to the right and down of that digit and selected every 7th number to reach the required 60 envelops with random numbers). For each participants, a new envelope was opened and those with odd number allocate to phacoemulsification group and those with even number allocated to the phacotrabeculectomy group.
-
Blinding (investigator's opinion)
-
Not blinded
-
Blinding description
-
-
Placebo
-
Not used
-
Assignment
-
Parallel
-
Other design features
-
The main purpose of the study is to investigate the effect of either surgical method on the anterior chamber drainage angle.
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2015-05-21, 1394/02/31
-
Ethics committee reference number
-
IR.MUMS.REC.1394.262
Health conditions studied
1
-
Description of health condition studied
-
Glaucoma
-
ICD-10 code
-
H40
-
ICD-10 code description
-
Glaucoma
2
-
Description of health condition studied
-
cataract
-
ICD-10 code
-
H25
-
ICD-10 code description
-
Age-related cataract
Primary outcomes
1
-
Description
-
Intraocular pressure (IOP)
-
Timepoint
-
Postoperative 1st week, 1st month, 6th and month
-
Method of measurement
-
IOP measurement with Goldmann applanation tonometer
2
-
Description
-
Angle opening distance at 500 micron (AOD500)
-
Timepoint
-
Before surgery, 1 week, 1 month and 6 months after surgery
-
Method of measurement
-
Measuring AOD using Casia AS-OCT device (Tomey)
3
-
Description
-
Trabecular iris angle at 500 micron (TIA500)
-
Timepoint
-
Before surgery; 1 week, 1 month and 6 months after surgery
-
Method of measurement
-
Measuring TIA using Casia ASOCT (Tomey)
4
-
Description
-
Trabecular-iris surface area (TISA)
-
Timepoint
-
Before surgery; 1 week, 1 month and 6 months after surgery
-
Method of measurement
-
Measuring TIA using Casia ASOCT (Tomey)
Intervention groups
1
-
Description
-
In intervention group, the patients undergo phacoemulsification cataract surgery with a temporal incision and posterior chamber intraocular lens (PCIOL) implantation in the capsular bag. At the conclusion of cataract surgery and in the same session, a superior fornix-based trabeculectomy with intraoperative mitomycin-c is done for the patients.
-
Category
-
Treatment - Surgery
2
-
Description
-
In the control group, the patients undergo temporal phacoemulsification and in the bag PCIOL implantation. No separate, additional glaucoma surgery is done in this group.
-
Category
-
Treatment - Surgery
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
930126
-
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
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
-
Deidentified, anonymous participants data are available in a MS Excel file.
-
When the data will become available and for how long
-
One year after publication of the article.
-
To whom data/document is available
-
Other researcher, upon written request
-
Under which criteria data/document could be used
-
Accreditation and meta-analysis
-
From where data/document is obtainable
-
Written request, directed to corresponding person or PI
-
What processes are involved for a request to access data/document
-
Upon approval of the request by Vice chancellor of Research at MUMS and the legal authorities, the information would be send to the requester.
-
Comments
-