Other Iris and Ciliary Body DisordersNCT02215057
Evaluation of Topical Anesthesia Alone Versus Combined With Intracameral LIdocaine 1%
A study testing topical anesthesia and topical anesthesia plus intracameral lidocaine 1% in people with Other Iris and Ciliary Body Disorders, run by Cairo University at 1 site in Saudi Arabia.
Trial summary
General anesthesia may be non preferable in many patients undergoing Phakic IOL surgery, as most of the surgeries take 5-10 minutes at maximum.Traditionally, retrobulbar injections were performed deep into the orbit, but it is now accepted that peribulbar injections using shorter needles are safer. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Other Iris and Ciliary Body Disorders
- What is being tested?
- topical anesthesia and topical anesthesia plus intracameral lidocaine 1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Aug 2014to Oct 2014
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- any age
- calm patient
- agreed
Who cannot join
- co agulopathy anxious refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Topical Anesthesia Alone Versus Combined With Intracameral Lidocaine 1% in Patients Undergoing Implantable Collamer Lens (ICL) Procedure
General anesthesia may be non preferable in many patients undergoing Phakic IOL surgery, as most of the surgeries take 5-10 minutes at maximum.Traditionally, retrobulbar injections were performed deep into the orbit, but it is now accepted that peribulbar injections using shorter needles are safer. In the last few years, continuing concern over the rare but serious complications of sharp needle blocks has led to increasing interest in the use of sub-Tenon's blocks utilizing a blunt cannula 1-5.
Even with the use of blunt canulae sub-Tenon's block, serious problems can still occur, especially in myopic patients with large axial length. In phakic IOL surgery,topical anesthesia has been used successfully for years. Topical anesthesia has several advantages over regional infiltrative techniques, the foremost of which is the abolition of any risk of inadvertent injury of the globe or orbital contents 6,7,8. It has a high rate of patient satisfaction, but still there are some patients that experience intraoperative discomfort.
In this study we compared topical anesthesia alone with topical anesthesia plus intracameral lidocaine 1% in patients undergoing posterior chamber phakic intra ocular lens;Vision implantable collamer lens ( ICL/toric ICL) surgery.Intracameral anesthesia is a common adjunct to topical anesthesia in anterior segment surgery9. It probably provides sensory blockage of the iris and ciliary body and thereby relieves discomfort experienced during IOL placement. Intracameral lidocaine alone dilates the pupil well 10 and this is believed to be because of the direct action of lidocaine on the iris, which in turn causes muscle relaxation.
Read the detailed description
were enrolled in this study after obtaining approval from the institutional ethical committee and written patients consent. We estimated our sample size based on a method described by Lerman. A sample size of 45 will detect a 20% difference between each group; this will give an alpha value of 0.05 with a power of 80%. With a fall-out rate of approximately 19%, we decided to increase the number of patients in each group to 51.All patients were assessed and only those who were deemed suitable for topical and intracameral lidocaine 1% were included in the study.Very anxious patients were omitted from the study.
We are planning a study of matched sets of patients receiving the experimental and control treatments with 1 matched control(s) per experimental subject. Prior data indicate that the probability of a treatment failure among controls is 0.05 and the correlation coefficient for exposure between matched experimental and control subjects are 0.1. If the true odds ratio for failure in experimental subjects relative to control subjects is 0.1, we will need to study 51 experimental subjects with 1 matched control(s) per experimental subject to be able to reject the null hypothesis that this odds ratio equals 1 with probability (power) 0.7. The Type I error probability associated with this test of this null hypothesis is 0.3.
All the operations were done by one surgeon (SE).Patients were prepared for bilateral ICL/TICL procedure on the same day.Group I (1 eye) received topical anesthetic drops and Group 2 (the second eye) received topical anesthesia plus intracameral lidocaine 1% at the start of sugery through the 3.00 mm corneal incision. Before giving the anesthetics, a peripheral vein was cannulated and heart rate, oxygen saturation and non-invasive arterial blood pressure were monitored.Topical anesthesia was done with 2% tetracaine local anesthetic drops .
Pain was estimated by the patient using a simple pain score: no pain =0; that does not interfere with the surgical technique, discomfort=1; the surgical technique is performed with difficulty, pain=2; the surgeon is unable to continue the surgical technique. The scoring was done during different stages of surgery: lid retraction while inserting a speculum, tolerance to the microscope light, corneal incision, intraocular lens insertion, tucking of footplates, irrigation and aspiration (I/A) of viscoelastic, and peripheral iridectomy. The surgical technique was performed through a clear corneal 3.0 mm tunnel incision, followed by sodium hyaluronate injection, ICL/toricICL implantation(V4B,STAAR,California,USA) and unfolding, tucking of trailing footplates then side port incision and tucking of leading footplates, MIOSTAT 0.01% (Alcon,Texas,USA) injection, then peripheral iridectomy .
- Conditions
- Other Iris and Ciliary Body Disorders
- Being tested
- topical anesthesia, topical anesthesia plus intracameral lidocaine 1%
- Keywords
- topical anesthesia, intracameral lidocaine, implantable collamer lens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topical anesthesiaDrug
Also called LOCAL ANESTHESIA
topical anesthetic drops and Group 2
topical anesthesia plus intracameral lidocaine 1%Drug
Also called received topical anesthesia plus intracameral lidocaine 1%
received topical anesthesia plus intracameral lidocaine 1%
| Study group | Role | What they receive |
|---|---|---|
| Group 2 | Experimental | topical anesthetic drops patients were prepared for bilateral ICL/TICL procedure on the same day.Group I (1 eye) received topical anesthetic drops Receives: Drug: topical anesthesia |
| Group 1 | Experimental | received topical anesthesia plus intracameral lidocaine 1% topical anesthesia plus intracameral lidocaine 1%' Receives: Drug: topical anesthesia; Drug: topical anesthesia plus intracameral lidocaine 1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
PAIN
Measured: 15 MINUTES
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Other Iris and Ciliary Body DisordersStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hassan Mohamed Ali, Cairo University
- Investigators
- Hassan M Ali, Lecturer, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02215057
- Sponsor's protocol ID
- 1479
- Status last verified
- Aug 2016
- First submitted
- 11 Aug 2014
- Last updated
- 4 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Topical Anesthesia Alone Versus Combined With Intracameral Lidocaine 1% in Patients Undergoing Implantable Collamer Lens (ICL) Procedure
- ClinicalTrials.gov ID
- NCT02215057
- Acronym / sponsor ID
- 1479
- Conditions
- Other Iris and Ciliary Body Disorders
- Keywords
- topical anesthesia, intracameral lidocaine, implantable collamer lens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 13 Aug 2014 (estimated)
- 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.
General anesthesia may be non preferable in many patients undergoing Phakic IOL surgery, as most of the surgeries take 5-10 minutes at maximum.Traditionally, retrobulbar injections were performed deep into the orbit, but it is now accepted that peribulbar injections using shorter needles are safer. In the last few years, continuing concern over the rare but serious complications of sharp needle blocks has led to increasing interest in the use of sub-Tenon's blocks utilizing a blunt cannula 1-5.
Even with the use of blunt canulae sub-Tenon's block, serious problems can still occur, especially in myopic patients with large axial length. In phakic IOL surgery,topical anesthesia has been used successfully for years. Topical anesthesia has several advantages over regional infiltrative techniques, the foremost of which is the abolition of any risk of inadvertent injury of the globe or orbital contents 6,7,8. It has a high rate of patient satisfaction, but still there are some patients that experience intraoperative discomfort.
In this study we compared topical anesthesia alone with topical anesthesia plus intracameral lidocaine 1% in patients undergoing posterior chamber phakic intra ocular lens;Vision implantable collamer lens ( ICL/toric ICL) surgery.Intracameral anesthesia is a common adjunct to topical anesthesia in anterior segment surgery9. It probably provides sensory blockage of the iris and ciliary body and thereby relieves discomfort experienced during IOL placement. Intracameral lidocaine alone dilates the pupil well 10 and this is believed to be because of the direct action of lidocaine on the iris, which in turn causes muscle relaxation.
Detailed description
were enrolled in this study after obtaining approval from the institutional ethical committee and written patients consent. We estimated our sample size based on a method described by Lerman. A sample size of 45 will detect a 20% difference between each group; this will give an alpha value of 0.05 with a power of 80%. With a fall-out rate of approximately 19%, we decided to increase the number of patients in each group to 51.All patients were assessed and only those who were deemed suitable for topical and intracameral lidocaine 1% were included in the study.Very anxious patients were omitted from the study.
We are planning a study of matched sets of patients receiving the experimental and control treatments with 1 matched control(s) per experimental subject. Prior data indicate that the probability of a treatment failure among controls is 0.05 and the correlation coefficient for exposure between matched experimental and control subjects are 0.1. If the true odds ratio for failure in experimental subjects relative to control subjects is 0.1, we will need to study 51 experimental subjects with 1 matched control(s) per experimental subject to be able to reject the null hypothesis that this odds ratio equals 1 with probability (power) 0.7. The Type I error probability associated with this test of this null hypothesis is 0.3.
All the operations were done by one surgeon (SE).Patients were prepared for bilateral ICL/TICL procedure on the same day.Group I (1 eye) received topical anesthetic drops and Group 2 (the second eye) received topical anesthesia plus intracameral lidocaine 1% at the start of sugery through the 3.00 mm corneal incision. Before giving the anesthetics, a peripheral vein was cannulated and heart rate, oxygen saturation and non-invasive arterial blood pressure were monitored.Topical anesthesia was done with 2% tetracaine local anesthetic drops .
Pain was estimated by the patient using a simple pain score: no pain =0; that does not interfere with the surgical technique, discomfort=1; the surgical technique is performed with difficulty, pain=2; the surgeon is unable to continue the surgical technique. The scoring was done during different stages of surgery: lid retraction while inserting a speculum, tolerance to the microscope light, corneal incision, intraocular lens insertion, tucking of footplates, irrigation and aspiration (I/A) of viscoelastic, and peripheral iridectomy. The surgical technique was performed through a clear corneal 3.0 mm tunnel incision, followed by sodium hyaluronate injection, ICL/toricICL implantation(V4B,STAAR,California,USA) and unfolding, tucking of trailing footplates then side port incision and tucking of leading footplates, MIOSTAT 0.01% (Alcon,Texas,USA) injection, then peripheral iridectomy .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 2 | Experimental | Drug: topical anesthesiatopical anesthetic drops patients were prepared for bilateral ICL/TICL procedure on the same day.Group I (1 eye) received topical anesthetic drops |
| Group 1 | Experimental | Drug: topical anesthesia, Drug: topical anesthesia plus intracameral lidocaine 1%received topical anesthesia plus intracameral lidocaine 1% topical anesthesia plus intracameral lidocaine 1%' |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- any age
- calm patient
- agreed
Key exclusion criteria (1 listed)
- co agulopathy anxious refusal
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 |
|---|---|---|
| topical anesthesiaAlso: LOCAL ANESTHESIAtopical anesthetic drops and Group 2 | Drug | Group 1, Group 2 |
| topical anesthesia plus intracameral lidocaine 1%Also: received topical anesthesia plus intracameral lidocaine 1%received topical anesthesia plus intracameral lidocaine 1% | Drug | Group 1 |
Primary outcome
PAIN
Time frame: 15 MINUTES
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 4 Aug 2016.
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.
Hassan M Ali, Lecturer principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing topical anesthesia and topical anesthesia plus intracameral lidocaine 1% in people with Other Iris and Ciliary Body Disorders, run by Cairo University at 1 site in Saudi Arabia.
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 3 inclusion and 1 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 4 Aug 2016. 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 Saudi Arabia. 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?
PAIN (time frame: 15 MINUTES). 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 4 Aug 2016.