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Effect of Superficial Keratotomy on Reducing Postoperative Pain Fallowing Conjuctival Flap

I

Iran University of Medical Sciences

Status

Completed

Conditions

Reduced Corneal Sensation

Treatments

Procedure: corneal neurotomy

Study type

Interventional

Funder types

Other

Identifiers

NCT05494931
IR.IUMS.FMD.REC.1401.021

Details and patient eligibility

About

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.

Full 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.

Enrollment

9 patients

Sex

All

Volunteers

Accepts 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.)

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

9 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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