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Effect of Superficial Keratotomy on Reducing Postoperative Pain Fallowing Conjuctival Flap ;a Randomized Clinical Trial

Protocol summary

Study aim
To assess whether adding superficial keratotomy to the standard method of conjunctival flap is or is not associated with reduced posoperative pain
Design
Clinical trial with control and intervention group in parallel and double blind, phase 3 is performed on 16 patients. For random assignment of patients to two groups, quadruple randomization blocks will be used:Balanced randomisation blocks
Settings and conduct
A randomized clinical trial will be performed at Hazrat Rasool Akram Hospital. In the first group, the same classical method of conj flap surgery is used and in the second group, conj flap surgery is performed with incision of the superficial radial nerves of the cornea. The pain of these two groups will be measured using visual analogue scale, after 6 hours, 24 hours and 48 hours and finally the average pain reduction in the two groups will be compared. Researcher number two is responsible for asking the patient is unaware that the patient belongs to the intervention or control group.
Participants/Inclusion and exclusion criteria
Inclusion criteri: Patients who are candidates for prosthesis implantation exclusion criteria: painful vision loss eye Patients who are candidates for conjunctival flap with indications other than implant placement (such as pain due to corneal ulcers)
Intervention groups
Patients are divided into two groups. In the first group, we use the classical Gunderson technique as the surgical procedure of choice. In the second group, we use the modified surgical method, conj flap operation with cutting the superficial nerves of the cornea. After 6 hours, 24 hours and 48 hours after surgery, both groups of patients are asked to express their pain on the VAS scale.
Main outcome variables
Pain score based on VAS

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220424054640N2
Registration date: 2022-05-14, 1401/02/24
Registration timing: prospective

Last update: 2022-05-14, 1401/02/24
Update count: 0
Registration date
2022-05-14, 1401/02/24
Registrant information
Name
Nasser Karimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 912 327 2376
Email address
drnasserkarimi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-21, 1401/02/31
Expected recruitment end date
2022-08-20, 1401/05/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Superficial Keratotomy on Reducing Postoperative Pain Fallowing Conjuctival Flap ;a Randomized Clinical Trial
Public title
Effect of Superficial Keratotomy on Reducing Postoperative Pain Fallowing Conjuctival Flap.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
VLE (vision loss eye) Patients who are candidates for prosthesis implantation
Exclusion criteria:
Patients who are candidates for conjunctival flap with indications other than implant placement (such as pain due to corneal ulcers, etc.) painful vision loss eye
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 16
More than 1 sample in each individual
Number of samples in each individual: 8
In the control group, we use the classical Gunderson technique as the surgical procedure . In the intervention group, we use the modified surgical method, the conj flap operation with cutting the superficial nerves of the cornea.
Randomization (investigator's opinion)
Randomized
Randomization description
For random assignment of patients to two groups, random codes in balanced quadruple blocks will be used as follows: 1.AA BB 2.AB AB 3.BB AA 4.BA BA
Blinding (investigator's opinion)
Double blinded
Blinding description
Researcher number two is responsible for asking how much pain the patient has at 6 24 48 hours after the operation and at the time of question he is unaware that the patient belongs to the intervention or control group. (Blind access)
Placebo
Not used
Assignment
Parallel
Other design features
Patients are divided into two groups. In the first group, we use the classical Gunderson technique as the surgical procedure . In the second group, we use the modified surgical method, the conj flap operation with cutting the superficial nerves of the cornea. All surgeries are performed under general anesthesia. In surgery, a knife is used and the depth of the incisions is enough to reach the midd stroma. Trephinen will also be used in cases where the diameter of the cornea is higher than 8 mm. It will be used and we will cut it. After the pan-pressure operation, pressure will be applied for three days and 5 acetaminophen tablets will be prescribed for all patients with a prescription every 4 hours. If the patient needs more painkillers, in Patient data are recorded. Due to the fact that the patient's eye is bandaged in the first three days, we will not use topical corticosteroids for up to three days after opening the bandage, which coincides with the first visit on the third day after surgery. Topical steroid drops should be started four times a day for the patient and no oral corticosteroids should be used. The title of the cutting guide will be used after the trephinen horizontal and vertical cuts on the surface of the century One will be done by the surgeon with a knife at the same depth of 300. In cases where the diameter of the cornea is less than 8 mm, the surgeon tries to extend the incision depth to the middle of the stroma. After 6 hours, 24 hours and 48 hours after surgery, both groups of patients are asked to express their pain on the VAS scale. Visual analogue scale (VAS) is one of the best methods available for estimating pain intensity. VAS is a 10 cm line printed on a piece of paper with a marker at the end. It is "painless" at one end and "worst pain" or "indescribable pain" at the other. The patient places a mark on the line to indicate pain, and then the mark is measured with a ruler to obtain a score. The mean scores of the two groups are calculated using the Tscore method and finally the mean postoperative pain intensity in the two selected groups will be compared.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Iran university of medical sciences
Street address
Niyayesh St., Satarkhan St.
City
Tehran
Province
Tehran
Postal code
1445613131
Approval date
2022-03-18, 1400/12/27
Ethics committee reference number
Ethics committee reference number

Health conditions studied

1

Description of health condition studied
Severe visual impairment, monocular
ICD-10 code
H54.5
ICD-10 code description
Severe visual impairment, monocular

Primary outcomes

1

Description
In the study of the effect of superficial corneal incisions in reducing pain in patients after conjunctival flap surgery, primary outcome can be the pain score after Corneal neurotomy .
Timepoint
In the study of the effect of superficial corneal incisions in reducing pain in patients after conjunctival flap surgery, pain score measurement can be 6 24 48 hours after corneal neurotomy
Method of measurement
In studying the effect of superficial corneal incisions in reducing pain in patients after conjunctival flap surgery, how to measure pain score can be using VSA(visual analogue scale )

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:we use the modified surgical method, the conj flap operation with cutting the superficial nerves of the cornea.
Category
Prevention

2

Description
Control group:we use the classical Gunderson technique as the surgical procedure
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasool Akram Hospital
Full name of responsible person
Nasser Karimi
Street address
Niyayesh St., Satarkhan St.
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 912 327 2376
Fax
+98 21 6435 1000
Email
drnasserkarimi@gmail.com
Web page address
http://www.eyeresearch_center.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Nasser Karimi
Street address
Niyayesh St., Satarkhan St.
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 912 327 2376
Fax
+98 21 6435 1000
Email
drnasserkarimi@gmail.com
Web page address
https://iraneyeresearch.iums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Dr.Nasser Karimi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Niyayesh St., Satarkhan St.
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6655 8811
Fax
+98 21 6655 8811
Email
drnasserkarimi@gmai.com
Web page address
https://iraneyeresearch.iums.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Nasser Karimi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Niyayesh street, Satarkhan street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6655 8811
Email
drnasserkarimi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Nasser Karimi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Niyayesh street, Satarkhan street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6655 8811
Fax
+98 21 6655 8811
Email
drnasserkarimi@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not 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
We intend to share the results as an article
When the data will become available and for how long
At the end of project 1 year
To whom data/document is available
All
Under which criteria data/document could be used
All academic research
From where data/document is obtainable
Dr karimi instagram @drnasserkarimi
What processes are involved for a request to access data/document
Within 1 week of request
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