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Effect of Superficial Keratotomy on Reducing Postoperative Pain Fallowing Conjuctival Flap

Primary Purpose

Reduced Corneal Sensation

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
corneal neurotomy
Sponsored by
Iran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Reduced Corneal Sensation focused on measuring keratotomy.conjuctival flap.radial corneal nerve

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • VLE (vision loss eye)Patients who are candidates for prosthesis implantation

Exclusion Criteria:

  • 1 painful vision loss eye
  • 2 Patients who are candidates for conjunctival flap with indications other than implant placement (such as pain due to corneal ulcers, etc.)

Sites / Locations

  • Eye Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

control group

intervention group

Arm Description

In this first group, the same classic method of Gunderson conjunctival flap surgery will be used.

in the this group, Gunderson conjunctival flap surgery will be performed adjuncted by corneal neurotomy

Outcomes

Primary Outcome Measures

postoperative pain 6 hours after conjunctival flap
measured via self-reported visual analogue scale (0 -10) , higher score means more severe pain
postoperative pain 24 hours after conjunctival flap
measured via self-reported visual analogue scale (0 -10) , higher score means more severe pain
postoperative pain 48 hours after conjunctival flap
measured via self-reported visual analogue scale (0 -10) , higher score means more severe pain

Secondary Outcome Measures

Full Information

First Posted
August 5, 2022
Last Updated
August 9, 2022
Sponsor
Iran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05494931
Brief Title
Effect of Superficial Keratotomy on Reducing Postoperative Pain Fallowing Conjuctival Flap
Official Title
Effect of Superficial Keratotomy on Reducing Postoperative Pain Fallowing Conjuctival Flap
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
December 15, 2020 (Actual)
Primary Completion Date
June 5, 2022 (Actual)
Study Completion Date
August 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Iran University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
During conjunctival flap surgery the corneal epithelium is removed and a conjunctival flap is placed on the cornea and after a few weeks the conjunctiva covers the surface of the eye. Complications of this operation are flap retraction, conjunctival inclusion cysts, bleeding, infection and pain. Pain is one of the main complications of conjunctival flap surgery. Two sources are conceivable for pain: 1) conjunctival pain 2) corneal pain, the second of which is the main part of the pain. Numerous methods for controlling corneal pain have been reported in various articles. Eye patches are often recommended for the treatment of corneal abrasions despite the lack of evidence. Recommended analgesics to control corneal scratch pain include nonsteroidal anti-inflammatory drugs (NSAIDs), local anesthetics, and topical cycloplegias. In this article, we are going to review and evaluate a new method called corneal neuorotomy, i.e., corneal nerve endings that inserted radially can be cut to reduce postoperative pain.
Detailed Description
The main idea of this randomized clinical trial is to test the extent of pain relief after incision of radial corneal nerve endings. Patients are divided into two groups. In the first group, the same classic method of conjunctival flap surgery was used and in the second group, conjunctival flap surgery was performed adjuncted by cutting the radial superficial nerves of the cornea. The postoperative pain scores of these two groups will be measured using visual analogue scale, after 6 hours, 24 hours and 48 hours, and finally the average pain of the two groups will be compared.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reduced Corneal Sensation
Keywords
keratotomy.conjuctival flap.radial corneal nerve

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
No Intervention
Arm Description
In this first group, the same classic method of Gunderson conjunctival flap surgery will be used.
Arm Title
intervention group
Arm Type
Active Comparator
Arm Description
in the this group, Gunderson conjunctival flap surgery will be performed adjuncted by corneal neurotomy
Intervention Type
Procedure
Intervention Name(s)
corneal neurotomy
Intervention Description
Classic Gunderson conjunctival flap surgery adjuncted by corneal neurotomy
Primary Outcome Measure Information:
Title
postoperative pain 6 hours after conjunctival flap
Description
measured via self-reported visual analogue scale (0 -10) , higher score means more severe pain
Time Frame
6 hours after surgery
Title
postoperative pain 24 hours after conjunctival flap
Description
measured via self-reported visual analogue scale (0 -10) , higher score means more severe pain
Time Frame
24 hours after surgery
Title
postoperative pain 48 hours after conjunctival flap
Description
measured via self-reported visual analogue scale (0 -10) , higher score means more severe pain
Time Frame
48 hours after surgery

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: VLE (vision loss eye)Patients who are candidates for prosthesis implantation Exclusion Criteria: 1 painful vision loss eye 2 Patients who are candidates for conjunctival flap with indications other than implant placement (such as pain due to corneal ulcers, etc.)
Facility Information:
Facility Name
Eye Research Center
City
Tehran
State/Province
Tehrani
ZIP/Postal Code
1445913914
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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Effect of Superficial Keratotomy on Reducing Postoperative Pain Fallowing Conjuctival Flap

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