Effect of Superficial Keratotomy on Reducing Postoperative Pain Fallowing Conjuctival Flap

Sponsor

Iran University of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT05494931

Collaborator

(none)

Enrollment

Location

Arms

19.6

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Reduced Corneal Sensation	Procedure: corneal neurotomy	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

9 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Effect of Superficial Keratotomy on Reducing Postoperative Pain Fallowing Conjuctival Flap

Actual Study Start Date :

Dec 15, 2020

Actual Primary Completion Date :

Jun 5, 2022

Actual Study Completion Date :

Aug 5, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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 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 48 hours after conjunctival flap [48 hours after surgery]
measured via self-reported visual analogue scale (0 -10) , higher score means more severe pain

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eye Research Center	Tehran	Tehrani	Iran, Islamic Republic of	1445913914

Sponsors and Collaborators

Iran University of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nasser Karimi, Principal Investigator, Assistant Professor, Iran University of Medical Sciences

ClinicalTrials.gov Identifier:

NCT05494931

Other Study ID Numbers:

IR.IUMS.FMD.REC.1401.021

First Posted:

Aug 10, 2022

Last Update Posted:

Aug 10, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Nasser Karimi, Principal Investigator, Assistant Professor, Iran University of Medical Sciences

keratotomy.conjuctival flap.radial corneal nerve

Additional relevant MeSH terms:

Pain, Postoperative

Study Results

No Results Posted as of Aug 10, 2022