Comparison of the surgical outcome of primary phaco-shunt versus primary phacotrabeculectomy in patients with concomitant cataract and glaucoma: A Randomized Clinical Trial
Comparison of success rate of primary phaco-shunt versus primary phacotrabeculectomy in patients with concomitant cataract and glaucoma
Design
A clinical trial study with two parallel groups, Randomized using computer permuted block randomization, There are 40 patients in each group and they are followed up for at least 6 months.
Settings and conduct
This study is performed on patients referred to the glaucoma clinic of Rasoul Akram Hospital in Tehran. Eligible patients are included in the study. First, the background information is recorded and thoroughly examined.Then they are randomly divided into two groups. Combined phacotrabeculectomy and phaco-shunt surgery are performed. In phyco-trab surgery, first cataract surgery is performed and then trabeculectomy is performed in the superior part. In phaco-shunt group, first shunt fixation and then cataract surgery are performed and then shunt tube is inserted into the eye. Then undergo regular examinations and two methods are compared in terms of success rate and possible complication.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with concomitant glaucoma and cataract that need combined surgery, type of glaucoma is open angle glaucoma
Exclusion criteria: Patients have more than 18 years old, type of glaucoma is other than open angle glaucoma, No history of glaucoma surgery
Intervention groups
In primary phaco-trab group, patients undergo combined phacoemulsification with trabeculectomy. In phaco-shunt group, patients undergo combined phacoemulsification with Ahmed Glaucoma Valve implantation.
Main outcome variables
Success rate; complication rate; Intra Ocular Pressure (IOP) before and after surgery; number of medication before and after surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210901052357N1
Registration date:2022-01-04, 1400/10/14
Registration timing:registered_while_recruiting
Last update:2022-01-04, 1400/10/14
Update count:0
Registration date
2022-01-04, 1400/10/14
Registrant information
Name
Farhad Najafzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6694 5106
Email address
najafzadeh.farhad@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-22, 1400/06/31
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the surgical outcome of primary phaco-shunt versus primary phacotrabeculectomy in patients with concomitant cataract and glaucoma: A Randomized Clinical Trial
Public title
Comparison surgical outcome of primary phaco-shunt versus primary phacotrabeculectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with concomitant cataract and glaucoma that need combined surgery
Type of glaucoma is open angle glaucoma
Exclusion criteria:
Patients have more than 18 years old
Neovascular glaucoma
Patients with No Light Perception (NLP)
Diabetic patients with proliferative retinopathy or need frequent injection of IVB
History of previous surgery: glaucoma surgery, retina surgery and scleral buckling
History of cyclodestructive procedure
Patients have scare of conjectiva
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, we will use the random block method so that the number of samples in the two groups is the same. The blocks are considered as 4, with a and b representing the two study groups. All possible permutations for a block of 4 are as follows: aabb, abba, abab, bbaa, baab, baba. From these 6 permutations, one block will be selected at a simple random time. The reason for this is to reduce the likelihood that final allocations will be predictable. After selecting the block, the person will be assigned to group a or b in the same way.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
No 18, Karimi Alley , Patris St, Sattarkhan St.
City
Tehran
Province
Tehran
Postal code
1443674553
Approval date
2021-08-24, 1400/06/02
Ethics committee reference number
IR.IUMS.REC.1400.433
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
The primary outcome variable of this study is intraocular pressure, which is measured with a Goldmann Applanation Tonometer.
Timepoint
Preoperative intraocular pressure measurement and postoperative intraocular pressure measurements include: first day, first week, first month, third month, sixth month
Method of measurement
Intraocular pressure is measured using a Goldmann tonometer.
2
Description
Complications of combined surgery based on the type of surgical procedure.
Timepoint
Regular examinations after surgery include: first day, first week, first month and third month
Method of measurement
Through a thorough postoperative clinical examination.
Secondary outcomes
1
Description
Number of antiglaucoma drugs used before and after combination surgery.
Timepoint
Before surgery and 6 months after surgery
Method of measurement
By reviewing patient records
Intervention groups
1
Description
Intervention group: The group undergoing combined phaco-shunt surgery. In this method, Ahmad shunt valve model FP7 (New World Medical, LA) will be used, which is one of the most common shunts used in the world. First, the shunt is fixed and then cataract surgery is performed by phaco method. Finally, the shunt tube enters the eye and fixed with naylon 10.0 suture and then the conjunctiva close with 8-0 vicryl sutures . Postoperative patients undergo regular examinations according to a specific protocol to evaluate the effectiveness as well as possible complications.
Category
Treatment - Surgery
2
Description
Intervention group: The group undergoing combined phacotrabeculectomy surgery.In this method, patients are first subjected to cataract surgery by phaco method. Then trabeculectomy in the superior region begins with conjunctival peritomy. Then MMC material with a dose of 0.04% for 2 minutes is used to reduce postoperative fibrosis. Finally, a sclera flap is created and a keratectomy and an irdectomy are performed, and all incisions are closed with nylon 10.0 sutures.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
glaucoma clinic of Rasoul Akram Hospital in Tehran