Epinephrine ToxicityNCT05225597
The Effect of Intracameral Carbachol and Epinephrine on Choroidal Thickness
A study testing Intracameral administration of epinephrine and carbachol during cataract surgery in people with Epinephrine Toxicity and Cataract, run by Ordu University at 1 site in Turkey (Türkiye).
Trial summary
81 eyes of 81 patients undergoing cataract surgery were included in this prospective interventional study. During cataract surgery, intracameral carbachol was applied to 27 eyes, intracameral epinephrine was administered to 20 eyes and 34 eyes were the control group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epinephrine Toxicity, Cataract, Carbachol Adverse Reaction
- What is being tested?
- Intracameral administration of epinephrine and carbachol during cataract surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 30 Dec 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- over 18 years old
- patients with cataracts
Who cannot join
- hypertension and diabetes
- ocular problems such as uveitis, glaucoma, amblyopia
- maculopathy, retinal dystrophy
- any previous ocular surgery
- eye trauma
- congenital cataracts
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Intracameral Carbachol and Epinephrine Use on Choroidal Thickness After Uncomplicated Phacoemulsification
81 eyes of 81 patients undergoing cataract surgery were included in this prospective interventional study. During cataract surgery, intracameral carbachol was applied to 27 eyes, intracameral epinephrine was administered to 20 eyes and 34 eyes were the control group. Macular choroidal thickness measurement was performed before, 1 day, and 1 week after phacoemulsification surgery in all patients using optical coherence tomography.
Read the detailed description
This study consisted of three groups: epinephrine group, carbachol group, and control group. Intracameral carbachol and epinephrine was not used for complication management. In the epinephrine group, 0.2 mL of epinephrine (1:5000 solution) was used immediately after making the clear corneal incision. In the carbachol group, a 0.5 ml dose of 0.01% carbachol solution (Miostat®, Alcon Laboratories, Inc., Fort Worth, TX) was given intracamerally immediately after viscoelastic matter removal following IOL implantation. The control group was given neither epinephrine nor carbachol.
Mydriasis was induced using combined 2.5% phenylephrine and 1.0% tropicamide topical drops before surgery. All surgeries were performed by the same surgeon (HBK) using a similar technique, under topical anesthesia (0.05% proparacaine HCL), and with a 2.8 mm temporal clear corneal incision. After making the incision, 0.2 mL of preservative-free epinephrine (1:5000) was injected into the epinephrine group only. A combination of 1.6% sodium hyaluronate and 4% chondroitin sulfate (ophthalmic viscosurgical device, Discovisc, Alcon Laboratories, Inc.) was used during capsulorhexis in all three groups, and Alcon Infiniti System (Alcon Laboratories Inc.) was used for phacoemulsification. A continuous curvilinear capsulorhexis of 4.5-5.5 mm was created. After complete hydrodissection, the nucleus was removed using the stop and chop technique. Phacoemulsification time (range: 30-60 s) was similar in all patients, while the phacoemulsification strength was set to 35%-40% for all operations. The cortex was aspirated in irrigation/aspiration mode. Before implanting a one-piece foldable hydrophobic acrylic IOL into the capsular bag, 1% sodium hyaluronate (ophthalmic viscosurgical device, Healon) was injected into the capsular bag. After removal of the viscoelastic material, only the carbachol group was given 0.5 ml of 0.01% carbachol solution intracamerally. Hydration with balanced salt solution was used to close the corneal incisions. Topical moxifloxacin, nepafenac, and prednisolone acetate eye drops were given to all patients six times a day for the first week. Prednisolone acetate was then reduced and discontinued 4 weeks after the operation.
- Being tested
- Intracameral administration of epinephrine and carbachol during cataract surgery
- Keywords
- choroidal thickness, carbachol, epinephrine, phacoemulsification, optical coherence tomography
- Medical subject headings
- Cataract, Choroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracameral administration of epinephrine and carbachol during cataract surgeryProcedure or surgery
All surgeries were performed by the same surgeon using a similar technique, under topical anesthesia (0.05% proparacaine HCL), and with a 2.8 mm temporal clear corneal incision. After making the incision, 0.2 mL of preservative-free epinephrine (1:5000) was injected into the epinephrine group only. After complete hydrodissection, the nucleus was removed using the stop and chop technique. Phacoemulsification time (range: 30-60 s) was similar in all patients, while the phacoemulsification strength was set to 35%-40% for all operations. The cortex was aspirated. Before implanting a one-piece foldable hydrophobic acrylic intraocular lens (IOL) into the capsular bag, 1% sodium hyaluronate (ophthalmic viscosurgical device, Healon) was injected into the capsular bag. After removal of the viscoelastic material, only the carbachol group was given 0.5 ml of 0.01% carbachol solution intracamerally. Hydration with balanced salt solution was used to close the corneal incisions.
| Study group | Role | What they receive |
|---|---|---|
| epinephrine | Active comparator | In the epinephrine group, 0.2 mL of epinephrine (1:5000 solution) was used immediately after making the clear corneal incision during cataract surgery Receives: Procedure: Intracameral administration of epinephrine and carbachol during cataract surgery |
| carbachol | Active comparator | In the carbachol group, a 0.5 ml dose of 0.01% carbachol solution (Miostat®, Alcon Laboratories, Inc., Fort Worth, TX) was given intracamerally immediately after viscoelastic matter removal following IOL implantation Receives: Procedure: Intracameral administration of epinephrine and carbachol during cataract surgery |
| control | No intervention | The control group was given neither epinephrine nor carbachol. Standard cataract surgery was performed |
What is being measured
The primary outcome is the main question the study is designed to answer.
choroidal thickness(CT)
CT measurement was performed using a Cirrus HD(high definition) 500 spectral OCT (optical coherence tomography) platform (Carl Zeiss Meditec, Dublin, California, USA). Subfoveal, nasal, temporal, lower choroidal thickness, and upper choroidal thickness were measured manually by two blinded observers with 0.5-mm intervals in vertical and horizontal sections having a length of 4 mm. The distance between the outer hyper-reflective border of the retinal pigment epithelium and the inner scleral surface was considered. Average data obtained by two observers were used in statistical analysis.
Measured: preoperatively, on postoperative day 1, and in postoperative week 1
Secondary outcomes (1)
intraocular pressure
Intraocular pressure was measured in all patients using a non-contact tonometer.
Measured: before, 1 day, and 1 week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start1 Jan 2021
- Primary completion30 Aug 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epinephrine ToxicityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study consisted of three groups: epinephrine group, carbachol group, and control group.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasan Burhanettin Kapti, Ordu University
- Investigators
- Hasan B Kaptı, MD, Principal investigator, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05225597
- Sponsor's protocol ID
- PANTONE 287 C
- Status last verified
- Feb 2022
- First submitted
- 14 Jan 2022
- Last updated
- 4 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intracameral Carbachol and Epinephrine Use on Choroidal Thickness After Uncomplicated Phacoemulsification
- ClinicalTrials.gov ID
- NCT05225597
- Acronym / sponsor ID
- PANTONE 287 C
- Keywords
- choroidal thickness, carbachol, epinephrine, phacoemulsification, optical coherence tomography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 4 Feb 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.
81 eyes of 81 patients undergoing cataract surgery were included in this prospective interventional study. During cataract surgery, intracameral carbachol was applied to 27 eyes, intracameral epinephrine was administered to 20 eyes and 34 eyes were the control group. Macular choroidal thickness measurement was performed before, 1 day, and 1 week after phacoemulsification surgery in all patients using optical coherence tomography.
Detailed description
This study consisted of three groups: epinephrine group, carbachol group, and control group. Intracameral carbachol and epinephrine was not used for complication management. In the epinephrine group, 0.2 mL of epinephrine (1:5000 solution) was used immediately after making the clear corneal incision. In the carbachol group, a 0.5 ml dose of 0.01% carbachol solution (Miostat®, Alcon Laboratories, Inc., Fort Worth, TX) was given intracamerally immediately after viscoelastic matter removal following IOL implantation. The control group was given neither epinephrine nor carbachol.
Mydriasis was induced using combined 2.5% phenylephrine and 1.0% tropicamide topical drops before surgery. All surgeries were performed by the same surgeon (HBK) using a similar technique, under topical anesthesia (0.05% proparacaine HCL), and with a 2.8 mm temporal clear corneal incision. After making the incision, 0.2 mL of preservative-free epinephrine (1:5000) was injected into the epinephrine group only. A combination of 1.6% sodium hyaluronate and 4% chondroitin sulfate (ophthalmic viscosurgical device, Discovisc, Alcon Laboratories, Inc.) was used during capsulorhexis in all three groups, and Alcon Infiniti System (Alcon Laboratories Inc.) was used for phacoemulsification. A continuous curvilinear capsulorhexis of 4.5-5.5 mm was created. After complete hydrodissection, the nucleus was removed using the stop and chop technique. Phacoemulsification time (range: 30-60 s) was similar in all patients, while the phacoemulsification strength was set to 35%-40% for all operations. The cortex was aspirated in irrigation/aspiration mode. Before implanting a one-piece foldable hydrophobic acrylic IOL into the capsular bag, 1% sodium hyaluronate (ophthalmic viscosurgical device, Healon) was injected into the capsular bag. After removal of the viscoelastic material, only the carbachol group was given 0.5 ml of 0.01% carbachol solution intracamerally. Hydration with balanced salt solution was used to close the corneal incisions. Topical moxifloxacin, nepafenac, and prednisolone acetate eye drops were given to all patients six times a day for the first week. Prednisolone acetate was then reduced and discontinued 4 weeks after the operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- This study consisted of three groups: epinephrine group, carbachol group, and control group.
| Arm | Type | Receives |
|---|---|---|
| epinephrine | Active comparator | Procedure: Intracameral administration of epinephrine and carbachol during cataract surgeryIn the epinephrine group, 0.2 mL of epinephrine (1:5000 solution) was used immediately after making the clear corneal incision during cataract surgery |
| carbachol | Active comparator | Procedure: Intracameral administration of epinephrine and carbachol during cataract surgeryIn the carbachol group, a 0.5 ml dose of 0.01% carbachol solution (Miostat®, Alcon Laboratories, Inc., Fort Worth, TX) was given intracamerally immediately after viscoelastic matter removal following IOL implantation |
| control | No intervention | –The control group was given neither epinephrine nor carbachol. Standard cataract surgery was performed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- over 18 years old
- patients with cataracts
Key exclusion criteria (6 listed)
- hypertension and diabetes
- ocular problems such as uveitis, glaucoma, amblyopia
- maculopathy, retinal dystrophy
- any previous ocular surgery
- eye trauma
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 |
|---|---|---|
| Intracameral administration of epinephrine and carbachol during cataract surgeryAll surgeries were performed by the same surgeon using a similar technique, under topical anesthesia (0.05% proparacaine HCL), and with a 2.8 mm temporal clear corneal incision. After making the incision, 0.2 mL of preservative-free epinephrine (1:5000) was injected into the epinephrine group only. After complete hydrodissection, the nucleus was removed using the stop and chop technique. Phacoemulsification time (range: 30-60 s) was similar in all patients, while the phacoemulsification strength was set to 35%-40% for all operations. The cortex was aspirated. Before implanting a one-piece foldable hydrophobic acrylic intraocular lens (IOL) into the capsular bag, 1% sodium hyaluronate (ophthalmic viscosurgical device, Healon) was injected into the capsular bag. After removal of the viscoelastic material, only the carbachol group was given 0.5 ml of 0.01% carbachol solution intracamerally. Hydration with balanced salt solution was used to close the corneal incisions. | Procedure or surgery | carbachol, epinephrine |
Primary outcome
choroidal thickness(CT)
Time frame: preoperatively, on postoperative day 1, and in postoperative week 1
CT measurement was performed using a Cirrus HD(high definition) 500 spectral OCT (optical coherence tomography) platform (Carl Zeiss Meditec, Dublin, California, USA). Subfoveal, nasal, temporal, lower choroidal thickness, and upper choroidal thickness were measured manually by two blinded observers with 0.5-mm intervals in vertical and horizontal sections having a length of 4 mm. The distance between the outer hyper-reflective border of the retinal pigment epithelium and the inner scleral surface was considered. Average data obtained by two observers were used in statistical analysis.
1 secondary outcome
intraocular pressure
Time frame: before, 1 day, and 1 week after surgery
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 Feb 2022.
- Individual participant dataSharing planned: No
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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.
Hasan B Kaptı, MD principal investigator
Ordu 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 Intracameral administration of epinephrine and carbachol during cataract surgery in people with Epinephrine Toxicity and Cataract, run by Ordu University at 1 site in Turkey (Türkiye).
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 2 inclusion and 6 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 Feb 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 Turkey (Türkiye). 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?
choroidal thickness(CT) (time frame: preoperatively, on postoperative day 1, and in postoperative week 1). 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 Feb 2022.