Comparison of one-step Fico surgery, intraocular lens implantation and silicone oil discharge with two-step silicone oil discharge procedure
Design
In the first group, discharge of silicone oil is performed through Pars Planana sclerotomy. In the second group, discharge of silicone oil is done by posterior capsular rex or Pars Plana sclerotomy. Silicone oil drainage surgery is performed at least 3 months after vitrectomy and silicone injection with complete retinal adhesion. Cataract surgery is performed when progressive lens opacity has reduced visual acuity in periodic examinations. To calculate the intraocular lens power in the presence of silicone oil, the ratio of sound velocity in silicon oil (986 m / s) to velocity in vitro (1555 m / s) is used. Lens power is determined by the IOL Master.
Settings and conduct
This prospective and non-randomized study was performed in Imam Khomeini Hospital in Ahvaz in 2018-2019.
Cataract surgery is performed with two approaches of superior or temporal incision followed by capsulorrhexis, followed by hydroduction, intra-capsular phacoemulsification and cortical material removal, viscoelastic gel injection, anterior chamber and capsular ligation, and capsular ligation.
Participants/Inclusion and exclusion criteria
All patients with cataract diagnosis after vitrectomy and injection of silicone oil that require cataract surgery and discharge of silicone oil are included in this study. Patients who did not return for follow-up or had other major ophthalmic surgeries with this type of surgery were excluded from the present study.
Intervention groups
The first group undergoes surgery in two stages. Silicone oil drainage surgery followed by cataract surgery in two stages. The second group undergoes cataract surgery and silicone oil drainage in one phase.
Main outcome variables
Improve vision, benefits and complications of one-stage and two-stage surgery
General information
Reason for update
Acronym
COTP
IRCT registration information
IRCT registration number:IRCT20191221045841N1
Registration date:2020-10-04, 1399/07/13
Registration timing:retrospective
Last update:2020-10-04, 1399/07/13
Update count:0
Registration date
2020-10-04, 1399/07/13
Registrant information
Name
feraidoon farahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3222 8076
Email address
farahi-f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-20, 1397/12/29
Expected recruitment end date
2019-09-21, 1398/06/30
Actual recruitment start date
2019-03-20, 1397/12/29
Actual recruitment end date
2019-09-21, 1398/06/30
Trial completion date
2019-09-21, 1398/06/30
Scientific title
Comparison of Phacoemulsification + IOL Implantation and Silicone Oil Removal in One Session with Performing These Operations in Two Sessions
Public title
Comparison of One Session and Two Sessions of Phacoemulsification
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
This study is non-randomized in Imam Khomeini Hospital in Ahvaz at 2019-2020.
Patients with a diagnosis of cataract after vitrectomy and silicone oil injection into the study.
Exclusion criteria:
Patients who did not return for follow-up.
major ophthalmic surgeries with this type of surgery were excluded.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
25
Actual sample size reached:
28
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals are divided into two groups based on the Four Random block permutation method.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Patients with cataract after vitrectomy and injection of silicone oil that require vitrectomy and discharge of silicone oil are divided into two groups at a specified interval.The first group undergoes surgery in two stages. Silicone oil drainage surgery followed by cataract surgery in two stages.The second group will undergo a single cataract surgery and discharge of silicone oil.In the first group, discharge of silicone oil is performed through Pars Planana sclerotomy. In the second group, discharge of silicone oil is done by posterior capsular rex or Pars Plana sclerotomy.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahwaz Jundishapour University of Medical Sciences
Street address
Imam Khomeini Street - Imam Khomeini Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2019-05-03, 1398/02/13
Ethics committee reference number
IR.AJUMS.REC.1398.130
Health conditions studied
1
Description of health condition studied
One-stage and two-stage Phaco surgery
ICD-10 code
H52.7
ICD-10 code description
Unspecified disorder of refraction
Primary outcomes
1
Description
Refraction
Timepoint
one week, one month, three month, six month
Method of measurement
autorefractometer
Secondary outcomes
1
Description
UCVA and BCVA
Timepoint
one week, one month, three month, six month
Method of measurement
autorefractometer
Intervention groups
1
Description
Intervention group: One-step - In this method, silicone oil is drained, cataract surgery and intraocular lens implantation are performed in one step. The equipment required in this method includes vitrectome device, vitrectome probe, fibropeptic light probe, Phaco device, silicone oil and intraocular lens.
Category
Treatment - Surgery
2
Description
Intervention group: Two Sessions- In this method, first the silicone oil is drained in one step and then the lens is inserted in the next step. The equipment required in this method includes vitrectome device, vitrectome probe, fibropeptic light probe, Phaco device, silicone oil and intraocular lens.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Khomaini Hospital
Full name of responsible person
Feraidoon Farrahi
Street address
Azadegan St
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 8076
Fax
Email
feraidoonfarrahi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Diyanat
Street address
Azadegan St
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 8076
Email
Habib.kakaei67@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Feraidoon Farrahi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Azadegan St
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 8076
Email
feraidoonfarrahi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Feraidoon Farrahi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Azadegan St
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 8076
Email
feraidoonfarrahi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Habibollah Kakaei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Azadegan St
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 8076
Email
Habib.kakaei67@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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Information on sample collection and analysis
When the data will become available and for how long
One years
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Similar studies
From where data/document is obtainable
Correspond Author
What processes are involved for a request to access data/document