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The Effect of Intracameral Carbachol and Epinephrine on Choroidal Thickness

Primary Purpose

Epinephrine Toxicity, Cataract, Carbachol Adverse Reaction

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Intracameral administration of epinephrine and carbachol during cataract surgery
Sponsored by
T.C. ORDU ÜNİVERSİTESİ
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epinephrine Toxicity focused on measuring choroidal thickness, carbachol, epinephrine, phacoemulsification, optical coherence tomography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • over 18 years old
  • patients with cataracts

Exclusion Criteria:

  • hypertension and diabetes
  • ocular problems such as uveitis, glaucoma, amblyopia
  • maculopathy, retinal dystrophy
  • any previous ocular surgery
  • eye trauma
  • congenital cataracts

Sites / Locations

  • Ordu University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

epinephrine

carbachol

control

Arm Description

In the epinephrine group, 0.2 mL of epinephrine (1:5000 solution) was used immediately after making the clear corneal incision during cataract surgery

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. Standard cataract surgery was performed

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

intraocular pressure
Intraocular pressure was measured in all patients using a non-contact tonometer.

Full Information

First Posted
January 14, 2022
Last Updated
February 2, 2022
Sponsor
T.C. ORDU ÜNİVERSİTESİ
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1. Study Identification

Unique Protocol Identification Number
NCT05225597
Brief Title
The Effect of Intracameral Carbachol and Epinephrine on Choroidal Thickness
Official Title
The Effect of Intracameral Carbachol and Epinephrine Use on Choroidal Thickness After Uncomplicated Phacoemulsification
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
August 30, 2021 (Actual)
Study Completion Date
December 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
T.C. ORDU ÜNİVERSİTESİ

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epinephrine Toxicity, Cataract, Carbachol Adverse Reaction, Choroid Disease
Keywords
choroidal thickness, carbachol, epinephrine, phacoemulsification, optical coherence tomography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study consisted of three groups: epinephrine group, carbachol group, and control group.
Masking
ParticipantOutcomes Assessor
Masking Description
Participants were unaware of the group in which they were assigned. The person evaluating the results did not know which result belonged to which group.
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
epinephrine
Arm Type
Active Comparator
Arm Description
In the epinephrine group, 0.2 mL of epinephrine (1:5000 solution) was used immediately after making the clear corneal incision during cataract surgery
Arm Title
carbachol
Arm Type
Active Comparator
Arm Description
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
Arm Title
control
Arm Type
No Intervention
Arm Description
The control group was given neither epinephrine nor carbachol. Standard cataract surgery was performed
Intervention Type
Procedure
Intervention Name(s)
Intracameral administration of epinephrine and carbachol during cataract surgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
choroidal thickness(CT)
Description
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.
Time Frame
preoperatively, on postoperative day 1, and in postoperative week 1
Secondary Outcome Measure Information:
Title
intraocular pressure
Description
Intraocular pressure was measured in all patients using a non-contact tonometer.
Time Frame
before, 1 day, and 1 week after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: over 18 years old patients with cataracts Exclusion Criteria: hypertension and diabetes ocular problems such as uveitis, glaucoma, amblyopia maculopathy, retinal dystrophy any previous ocular surgery eye trauma congenital cataracts
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hasan B Kaptı, MD
Organizational Affiliation
T.C. ORDU ÜNİVERSİTESİ
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ordu University
City
Ordu
State/Province
ABD Dışında
ZIP/Postal Code
52200
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Intracameral Carbachol and Epinephrine on Choroidal Thickness

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