Effect of Superficial Keratotomy on Reducing Postoperative Pain Fallowing Conjuctival Flap

NCT ID: NCT05494931

Last Updated: 2022-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-15
• Study Completion Date: 2022-08-05

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.

Conditions

Reduced Corneal Sensation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

intervention group

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

Group Type: ACTIVE_COMPARATOR

corneal neurotomy

Intervention Type: PROCEDURE

Classic Gunderson conjunctival flap surgery adjuncted by corneal neurotomy

Interventions

corneal neurotomy

Classic Gunderson conjunctival flap surgery adjuncted by corneal neurotomy

Intervention Type: PROCEDURE

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.)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Iran University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Nasser Karimi

Principal Investigator, Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Eye Research Center

Tehran, Tehrani, Iran

Countries

Iran

Other Identifiers

IR.IUMS.FMD.REC.1401.021

Identifier Type: -

Identifier Source: org_study_id