Ignite Creation Date:
2024-05-06 @ 7:19 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05978687
Status:
RECRUITING
Last Update Posted:
2023-10-17
First Post:
2023-07-03
Brief Title:
The Use of Lidocaine Gel Versus Subconjunctival Xylocaine Injection in Pterygium Excision
Sponsor:
Vrije Universiteit Brussel
Organization:
Vrije Universiteit Brussel
Study Overview
Official Title:
The Use of Lidocaine Ophtesic Gel Versus Subconjunctival Xylocaine Injection in Pterygium Excision
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LIDPTER
Brief Summary:
In pterygium excision procedures the subconjunctival injection of xylocain is regarded as an uncomfortable and painful step in the procedure While already being studied in other ophthalmic procedures such as glaucoma surgery 7 application of topical lidocaine gel is likely to minimize pain The gel has a longer surface contact time due to its consistency providing not only a longer anesthetic effect but protecting the corneal surface against desiccation when compared to eye drops
The investigators hypothesize that Ophtesic 2 lidocaine gel is as effective as an anesthetic in pterygium excision as subconjunctival injection while providing more comfort during surgery and less corneal dryness afterwards
Our goal is to compare both the anesthetic and corneal surface effect of topical 2 lidocaine gel to subconjunctival injection of xylocaine 2 solution with 0125 epinephrine in pterygium surgery
Compare the patients pain during and after surgery
Compare corneal dryness after surgery
Evaluate possible secondary events
The investigators hypothesize that Ophtesic 2 lidocaine gel is as effective as an anesthetic in pterygium excision as subconjunctival injection while providing more comfort during surgery and less corneal dryness afterwards
Our goal is to compare both the anesthetic and corneal surface effect of topical 2 lidocaine gel to subconjunctival injection of xylocaine 2 solution with 0125 epinephrine in pterygium surgery
Compare the patients pain during and after surgery
Compare corneal dryness after surgery
Evaluate possible secondary events
Detailed Description:
Pterygia are known as fibrovascular degenerations in the outer layer of the eye Usually they cross the limbus onto the cornea they develop over time and can cause symptoms such as redness itching irritation and decreased vision In severe cases pterygia can provoke binocular diplopia due to contraction of the Tenons capsule Risk factors are age UV exposure and male gender
Rezvan F et al conducted a meta-analysis to study the prevalance of pterygia in the world Their prevalence is estimated at 12 in the worldwide population being higher in subtropical regions They occur slightly more in men 13 versus 12 when compared to women The highest prevalence is seen in patients over 80 years old up to 195
The exact mechanism of pathogenesis is not clear A pterygium consists of degenerated collagen tissue Several previous studies have already proven the role of anti-apoptotic proteins such as p53 a tumor suppressor protein Its expression is elevated when compared to normal conjunctival tissue UV exposure is the most important risk factor This theory is supported by histopathologic actinic changes similar to actinic keratosis seen in pterygia
First line treatment for pterygia are conservative measures like lubricants and sunglasses to protect against additional harmful UV radiation Yet these measures are only symptomatic and will not eliminate the cause Surgery is regarded as an ideal solution in patients who would like a definitive improvement of esthetic and visual problems Several surgery techniques are already known but the most common is closure of the excised pterygium with a conjunctival auto graft In this technique conjunctiva from the superotemporal limbal part of the patients eye is used to cover the excised pterygium area A systematic review compared the risk of recurrence of this technique to the use of an amniotic membrane and concluded that the risk of recurrence was 46 percent less in the first group
These days subconjunctival injection of xylocaine 2 solution with 0125 epinephrine is the most used anesthesia technique The anesthesia is infero- or superotemporal administered 5-8mm from the limbus While giving excellent anesthetic result the pain and anxiety caused by this injection implied the need for new techniques In chalazion and cataract surgery lidocaine gel is already confirmed to have a sufficient anesthetic effect on patients while the amount of pain and anxiety during administration was decreased In pterygium surgery both and proves that pain was less during both anesthesia administration and post-operatively Now that Ophtesic lidocaine gel is also on-label for pterygium excision in many centers the gel is used as standard of care
With Oksuz et al 3 already having investigated the efficacy of lidocaine gel in pterygium surgery there might be more advantages yet to be investigated For example the lidocaine gel has the advantage of having a viscous consistency This allows the gel to protect the eye from desiccating during surgery Our primary goal in this study is to compare the ef-fect on dryness and irritation in patients after pterygium surgery with both methods of an-aesthesia by using the OSDI score questionnaire and the Oxford Dry Scale In addition to equal anaesthetic effect this could push the standard of care in favour of the lidocaine gel
In pterygium excision procedures the subconjunctival injection of xylocaine is regarded as an uncomfortable and painful step in the procedure Already proved to be equal the gel has a longer surface contact time due to its consistency providing not only a longer anesthetic effect but protecting the corneal surface against desiccation when compared to eye drops Nowadays it is already considered as the standard of care
The investigators hypothesize that Ophtesic 2 lidocaine gel is as effective as an anesthetic in pterygium excision as subconjunctival injection while providing more comfort during surgery and less corneal dryness afterwards
Our goal is to compare both the anesthetic and corneal surface effect of topical 2 lidocaine gel to subconjunctival injection of xylocaine 2 solution with 0125 epinephrine in pterygium surgery
Compare the patients pain during and after surgery
Compare corneal dryness after surgery
Evaluate possible secondary events eg enophtalmitis or non-adherence of the graft
Procedure Anesthesia In group A all patients will receive topical Povidone- Iodine and 2 lidocaine gel prior to surgery In group B all patients will receive Povidone- Iodine and a subconjunctival injection with xylocaine 2 hydrochloride solution with 0125 epinephrine will be injected with a 27-gauge needle When asked for patients will receive additional topical 1 lidocaine eye drops
Operative technique A traction suture is applied at the superior limbus Vicryl 60 with a Kocher The head of the pterygium is separated from its body with scissors Afterwards it is removed by blunt dissection The subconjunctival tissue under the body of the lesion is removed The conjunctival graft is separated from the Tenons capsule for harvest by ballooning with SBSS in group A and by injection with 05 mL of 2 xylocaine in group B The autograft is excised from the superior temporal side Hereafter the graft is secured to the recipient bed with sutures The traction suture is removed All operations are executed by the same surgeon
Following outcomes will be assessed
Pain The investigators will monitor pain assessment with the Visual Analogue Pain Scale Patients will be asked to give a score from 0 no pain at all to 10 worst pain imaginable The assessment is done intra- and post- operatively by a nurse of the department During both assessments the surgeon will leave the operating room
Pain will be monitored at following moments
Initial administration of anesthesia
At incision
Within 5 minutes after surgery
Day one post-operative consult
Dryness The dryness is assessed in two manners The Oxford Dry Eye Scale 11 Figure two will be handled as an objective tool to grade dryness The Ocular Surface Disease Index OSDI 12 Figure three four and five is a subjective manner of assessing dryness The questionnaire will be available in English Dutch and French
At following moments the dryness will be monitored
Day one post-operative consult
Day 8 post-operative consult
Exclusion criteria
History of auto-immune diseases such as Sjögren Lupus Graves Graft-versus-host disease rheumatoid arthritis
History of deafness anxiety disorders communicative barrier impossibility to comprehend the Visual Analogue Pain Scale or the OSDI questionnaire
Patient who already had pterygium excision
Rezvan F et al conducted a meta-analysis to study the prevalance of pterygia in the world Their prevalence is estimated at 12 in the worldwide population being higher in subtropical regions They occur slightly more in men 13 versus 12 when compared to women The highest prevalence is seen in patients over 80 years old up to 195
The exact mechanism of pathogenesis is not clear A pterygium consists of degenerated collagen tissue Several previous studies have already proven the role of anti-apoptotic proteins such as p53 a tumor suppressor protein Its expression is elevated when compared to normal conjunctival tissue UV exposure is the most important risk factor This theory is supported by histopathologic actinic changes similar to actinic keratosis seen in pterygia
First line treatment for pterygia are conservative measures like lubricants and sunglasses to protect against additional harmful UV radiation Yet these measures are only symptomatic and will not eliminate the cause Surgery is regarded as an ideal solution in patients who would like a definitive improvement of esthetic and visual problems Several surgery techniques are already known but the most common is closure of the excised pterygium with a conjunctival auto graft In this technique conjunctiva from the superotemporal limbal part of the patients eye is used to cover the excised pterygium area A systematic review compared the risk of recurrence of this technique to the use of an amniotic membrane and concluded that the risk of recurrence was 46 percent less in the first group
These days subconjunctival injection of xylocaine 2 solution with 0125 epinephrine is the most used anesthesia technique The anesthesia is infero- or superotemporal administered 5-8mm from the limbus While giving excellent anesthetic result the pain and anxiety caused by this injection implied the need for new techniques In chalazion and cataract surgery lidocaine gel is already confirmed to have a sufficient anesthetic effect on patients while the amount of pain and anxiety during administration was decreased In pterygium surgery both and proves that pain was less during both anesthesia administration and post-operatively Now that Ophtesic lidocaine gel is also on-label for pterygium excision in many centers the gel is used as standard of care
With Oksuz et al 3 already having investigated the efficacy of lidocaine gel in pterygium surgery there might be more advantages yet to be investigated For example the lidocaine gel has the advantage of having a viscous consistency This allows the gel to protect the eye from desiccating during surgery Our primary goal in this study is to compare the ef-fect on dryness and irritation in patients after pterygium surgery with both methods of an-aesthesia by using the OSDI score questionnaire and the Oxford Dry Scale In addition to equal anaesthetic effect this could push the standard of care in favour of the lidocaine gel
In pterygium excision procedures the subconjunctival injection of xylocaine is regarded as an uncomfortable and painful step in the procedure Already proved to be equal the gel has a longer surface contact time due to its consistency providing not only a longer anesthetic effect but protecting the corneal surface against desiccation when compared to eye drops Nowadays it is already considered as the standard of care
The investigators hypothesize that Ophtesic 2 lidocaine gel is as effective as an anesthetic in pterygium excision as subconjunctival injection while providing more comfort during surgery and less corneal dryness afterwards
Our goal is to compare both the anesthetic and corneal surface effect of topical 2 lidocaine gel to subconjunctival injection of xylocaine 2 solution with 0125 epinephrine in pterygium surgery
Compare the patients pain during and after surgery
Compare corneal dryness after surgery
Evaluate possible secondary events eg enophtalmitis or non-adherence of the graft
Procedure Anesthesia In group A all patients will receive topical Povidone- Iodine and 2 lidocaine gel prior to surgery In group B all patients will receive Povidone- Iodine and a subconjunctival injection with xylocaine 2 hydrochloride solution with 0125 epinephrine will be injected with a 27-gauge needle When asked for patients will receive additional topical 1 lidocaine eye drops
Operative technique A traction suture is applied at the superior limbus Vicryl 60 with a Kocher The head of the pterygium is separated from its body with scissors Afterwards it is removed by blunt dissection The subconjunctival tissue under the body of the lesion is removed The conjunctival graft is separated from the Tenons capsule for harvest by ballooning with SBSS in group A and by injection with 05 mL of 2 xylocaine in group B The autograft is excised from the superior temporal side Hereafter the graft is secured to the recipient bed with sutures The traction suture is removed All operations are executed by the same surgeon
Following outcomes will be assessed
Pain The investigators will monitor pain assessment with the Visual Analogue Pain Scale Patients will be asked to give a score from 0 no pain at all to 10 worst pain imaginable The assessment is done intra- and post- operatively by a nurse of the department During both assessments the surgeon will leave the operating room
Pain will be monitored at following moments
Initial administration of anesthesia
At incision
Within 5 minutes after surgery
Day one post-operative consult
Dryness The dryness is assessed in two manners The Oxford Dry Eye Scale 11 Figure two will be handled as an objective tool to grade dryness The Ocular Surface Disease Index OSDI 12 Figure three four and five is a subjective manner of assessing dryness The questionnaire will be available in English Dutch and French
At following moments the dryness will be monitored
Day one post-operative consult
Day 8 post-operative consult
Exclusion criteria
History of auto-immune diseases such as Sjögren Lupus Graves Graft-versus-host disease rheumatoid arthritis
History of deafness anxiety disorders communicative barrier impossibility to comprehend the Visual Analogue Pain Scale or the OSDI questionnaire
Patient who already had pterygium excision
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None