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CompletedNCT05494931Updated Aug 10, 2022

Effect of Superficial Keratotomy on Reducing Postoperative Pain Fallowing Conjuctival Flap

An interventional study of corneal neurotomy in Reduced Corneal Sensation, sponsored by Iran University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Per ClinicalTrials.gov, last updated 2022-08-10.

Sponsored by Iran University of Medical Sciences · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 7 months after the study started (first participant enrolled Dec 2020, registered Aug 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
9
Allocation
Randomized
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Reduced Corneal Sensation

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Keywords

  • keratotomy.conjuctival flap.radial corneal nerve
03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 9 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Iran University of Medical Sciences is the lead sponsor of 24 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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.)
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
9 participants (actual)

Study arms

  • 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

Interventions

  • Procedurecorneal neurotomy

    Classic Gunderson conjunctival flap surgery adjuncted by corneal neurotomy

06

What researchers measure

Primary outcomes

  1. postoperative pain 6 hours after conjunctival flap

    measured via self-reported visual analogue scale (0 -10) , higher score means more severe pain

    Time frame: 6 hours after surgery

  2. postoperative pain 24 hours after conjunctival flap

    measured via self-reported visual analogue scale (0 -10) , higher score means more severe pain

    Time frame: 24 hours after surgery

  3. postoperative pain 48 hours after conjunctival flap

    measured via self-reported visual analogue scale (0 -10) , higher score means more severe pain

    Time frame: 48 hours after surgery

07

Study locations

1 site
  • Eye Research Center
    Tehran, Tehrani 1445913914, Iran, Islamic Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05494931
Lead sponsor
Iran University of Medical Sciences
Responsible party
Nasser Karimi (Principal Investigator, Assistant Professor, Iran University of Medical Sciences) — Principal investigator
First posted
Aug 10, 2022
Start date
Dec 15, 2020
Primary completion
Jun 5, 2022
Completion
Aug 5, 2022
Last update
Aug 10, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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