Effect of Superficial Keratotomy on Reducing Postoperative Pain Fallowing Conjuctival Flap

Not Applicable

Completed

• Conditions: Reduced Corneal Sensation
• Interventions: Procedure: corneal neurotomy

• Registration Number: NCT05494931
• Lead Sponsor: Iran University of Medical Sciences

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.

Study Timeline

• Study Start: 2020-12-15
• Primary Completion: 2022-06-05
• Status Verified: 2022-08
• Study Completion: 2022-08-05
• Study First Submitted: 2022-08-05
• Study First Submitted QC: 2022-08-09
• Last Update Submitted: 2022-08-09
• Study First Posted: 2022-08-10
• Last Update Posted: 2022-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

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

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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.)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

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

Trial Locations

Locations (1)

Eye Research Center; 🇮🇷 Tehran, Tehrani, Iran, Islamic Republic of