Completed

NCT Number: NCT05494931

Effect of Superficial Keratotomy on Reducing Postoperative Pain Fallowing Conjuctival Flap

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.

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Key information

Conditions

Reduced Corneal Sensation

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eye Research Center

Tehran, Tehrani, 1445913914, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

corneal neurotomy

Procedure

Classic Gunderson conjunctival flap surgery adjuncted by corneal neurotomy

Primary outcomes

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
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
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

Sponsors and collaborators

Lead sponsor

Iran University of Medical Sciences

Other

Registry information

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2022
First posted: Aug 10, 2022
Registry last updated: Aug 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.