Effect of Superficial Keratotomy on Reducing Postoperative Pain Fallowing Conjuctival Flap

August 9, 2022 updated by: Nasser Karimi, Iran University of Medical Sciences

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
In this first group, the same classic method of Gunderson conjunctival flap surgery will be used.
Active Comparator: intervention group
in the this group, Gunderson conjunctival flap surgery will be performed adjuncted by corneal neurotomy
Procedure: corneal neurotomy
Classic Gunderson conjunctival flap surgery adjuncted by corneal neurotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative pain 6 hours after conjunctival flap
Time Frame: 6 hours after surgery
measured via self-reported visual analogue scale (0 -10) , higher score means more severe pain
6 hours after surgery
postoperative pain 24 hours after conjunctival flap
Time Frame: 24 hours after surgery
measured via self-reported visual analogue scale (0 -10) , higher score means more severe pain
24 hours after surgery
postoperative pain 48 hours after conjunctival flap
Time Frame: 48 hours after surgery
measured via self-reported visual analogue scale (0 -10) , higher score means more severe pain
48 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Iran University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2020

Primary Completion (Actual)

June 5, 2022

Study Completion (Actual)

August 5, 2022

Study Registration Dates

First Submitted

August 5, 2022

First Submitted That Met QC Criteria

August 9, 2022

First Posted (Actual)

August 10, 2022

Study Record Updates

Last Update Posted (Actual)

August 10, 2022

Last Update Submitted That Met QC Criteria

August 9, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IR.IUMS.FMD.REC.1401.021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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