Reduced Corneal SensationNCT05494931
Effect of Superficial Keratotomy on Reducing Postoperative Pain Fallowing Conjuctival Flap
A study testing corneal neurotomy in people with Reduced Corneal Sensation, run by Iran University of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Reduced Corneal Sensation
- What is being tested?
- corneal neurotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteIran
- Study dates
- 15 Dec 2020to 5 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- VLE (vision loss eye)Patients who are candidates for prosthesis implantation
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Reduced Corneal Sensation
- Being tested
- corneal neurotomy
- Keywords
- keratotomy.conjuctival flap.radial corneal nerve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
corneal neurotomyProcedure or surgery
Classic Gunderson conjunctival flap surgery adjuncted by corneal neurotomy
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | In this first group, the same classic method of Gunderson conjunctival flap surgery will be used. |
| intervention group | Active comparator | in the this group, Gunderson conjunctival flap surgery will be performed adjuncted by corneal neurotomy Receives: Procedure: corneal neurotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain 6 hours after conjunctival flap
measured via self-reported visual analogue scale (0 -10) , higher score means more severe pain
Measured: 6 hours after surgery
postoperative pain 24 hours after conjunctival flap
measured via self-reported visual analogue scale (0 -10) , higher score means more severe pain
Measured: 24 hours after surgery
postoperative pain 48 hours after conjunctival flap
measured via self-reported visual analogue scale (0 -10) , higher score means more severe pain
Measured: 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start15 Dec 2020
- Primary completion5 Jun 2022
- Study completion5 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reduced Corneal SensationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nasser Karimi, Iran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05494931
- Sponsor's protocol ID
- IR.IUMS.FMD.REC.1401.021
- Status last verified
- Aug 2022
- First submitted
- 5 Aug 2022
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Superficial Keratotomy on Reducing Postoperative Pain Fallowing Conjuctival Flap
- ClinicalTrials.gov ID
- NCT05494931
- Acronym / sponsor ID
- IR.IUMS.FMD.REC.1401.021
- Conditions
- Reduced Corneal Sensation
- Keywords
- keratotomy.conjuctival flap.radial corneal nerve
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Iran University of Medical SciencesUniversity, hospital or other
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 5 Jun 2022 (actual)
- Study completion
- 5 Aug 2022 (actual)
- First posted
- 10 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –In this first group, the same classic method of Gunderson conjunctival flap surgery will be used. |
| intervention group | Active comparator | Procedure: corneal neurotomyin the this group, Gunderson conjunctival flap surgery will be performed adjuncted by corneal neurotomy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- VLE (vision loss eye)Patients who are candidates for prosthesis implantation
Key exclusion criteria (2 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| corneal neurotomyClassic Gunderson conjunctival flap surgery adjuncted by corneal neurotomy | Procedure or surgery | intervention group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing corneal neurotomy in people with Reduced Corneal Sensation, run by Iran University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain 6 hours after conjunctival flap (time frame: 6 hours after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2022.