Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 6 of 10 for:    "Lens Disease" | "Phenylephrine"

Optimal Method for Mydriasis in Cataract Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02909140
Recruitment Status : Terminated (insufficient patient recruitment)
First Posted : September 21, 2016
Results First Posted : September 10, 2019
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
Obtaining appropriate mydriasis prior to cataract surgery is an important variable in successful surgery. The current practice includes using topical anticholinergic and sympathomimetic agents in the preoperative area prior to cataract surgery, but the pupils are sometimes insufficiently dilated and can often need additional mydriasis with intracameral agents during cataract surgery. Pre-operative topical mydriatic drops take time to take effect, are mildly uncomfortable for the patient, and have a cost to the healthcare system. If intracameral mydriasis alone can achieve adequate pupil dilation, perhaps topical mydriatics would not be needed. The purpose of this study is to evaluate whether topical versus intracameral versus topical + intracameral mydriasis is the optimal way to dilate pupils during routine cataract surgery. The results of this study have implications for improving the efficiency and reducing time prior to cataract surgery. In addition, it has significant potential to reduce the cost associated with cataract surgery if preoperative drops can be eliminated.

Condition or disease Intervention/treatment Phase
Cataract Drug: Topical phenylephrine 2.5% Drug: Topical cyclopentolate 1% Drug: Intracameral Lidocaine 1% Drug: Intracameral 0.2- 0.3ml of epinephrine 1:10,000 Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Optimal Method for Mydriasis in Cataract Surgery
Actual Study Start Date : September 2016
Actual Primary Completion Date : August 15, 2018
Actual Study Completion Date : August 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Experimental: Topical Mydriasis
Topical mydriasis will be with 1 drop of phenylephrine 2.5% and 1 drop of cyclopentolate 1% x 4 doses each, with each drop spaced 5 minutes apart given in the pre-op area. These are the standard dilating drops used for cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia.
Drug: Topical phenylephrine 2.5%
Drug: Topical cyclopentolate 1%
Drug: Intracameral Lidocaine 1%
Experimental: Intracameral Mydriasis
Intracameral mydriasis will be with 0.2ml to 0.3ml of epinephrine 1:10,000 injected into the anterior chamber at the beginning of the cataract surgery procedure. This is the standard concentration use for intracameral mydriasis in cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia.
Drug: Intracameral Lidocaine 1%
Drug: Intracameral 0.2- 0.3ml of epinephrine 1:10,000
Experimental: Topical + Intracameral mydriasis
Topical mydriasis will be with 1 drop of phenylephrine 2.5% and 1 drop of cyclopentolate 1% x 4 doses each, with each drop spaced 5 minutes apart given in the pre-op area. These are the standard dilating drops used for cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia. Intracameral mydriasis will be with 0.2ml to 0.3ml of epinephrine 1:10,000 injected into the anterior chamber at the beginning of the cataract surgery procedure. This is the standard concentration use for intracameral mydriasis in cataract surgery. These patients will also receive intracameral lidocaine 1% for anesthesia.
Drug: Topical phenylephrine 2.5%
Drug: Topical cyclopentolate 1%
Drug: Intracameral Lidocaine 1%
Drug: Intracameral 0.2- 0.3ml of epinephrine 1:10,000



Primary Outcome Measures :
  1. Pupil Size Immediately Prior to Capsulorrhexis [ Time Frame: Immediately prior to the capsulorrhexis step of cataract surgery ]
    Pupil size immediately prior to the capsulorrhexis step of cataract surgery. This will be recorded by digital photography and measured by a researcher who is masked to the intervention.


Secondary Outcome Measures :
  1. Pupil Size (mm) Immediately After Nuclear Disassembly [ Time Frame: Immediately after nuclear disassembly step of cataract surgery ]
    Pupil size immediately after breaking up of cataractous lens

  2. Pupil Size Immediately Prior to Intraocular Lens (IOL) Insertion [ Time Frame: Immediately prior to IOL insertion step of cataract surgery ]
    Pupil size after insertion of IOL lens

  3. Pupil Size Upon Completion of Surgery [ Time Frame: intraoperative ]
  4. Pupil Size on Post-operative Day 1 [ Time Frame: Post-operative Day 1 ]
  5. Percentage of Patients in Each Arm That Required Another Mydriatic Agent [ Time Frame: intraoperative ]
  6. Cumulative Energy Dispersed for Each Arm [ Time Frame: During cataract surgery ]
    The amount of energy needed to break up the cataractous lens

  7. Mean Time Taken to Perform Phacoemulsification in Each Arm [ Time Frame: intraoperative ]
  8. Percentage of Patients With an Increase in the Blood Pressure or Heart Rate [ Time Frame: Baseline ]
  9. Percentage of Patients With an Increase in the Blood Pressure or Heart Rate [ Time Frame: intraoperative ]
  10. Mean Time Taken to Perform Phacoemulsification [ Time Frame: During cataract surgery ]
  11. Percentage of Patients in Each Arm That Required Use of an Iris Expansion Device During the Procedure [ Time Frame: intraoperative ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients aged 40 or older who are undergoing routine cataract surgery under topical anesthesia with monitored anesthesia care at the Wilmer Eye Institute with Dr. Fasika Woreta and her senior resident proficient at cataract surgery.

Exclusion Criteria:

  • Need for general anesthesia
  • Maximum pupillary dilation <6.0mm at the pre-op clinic visit.
  • Prior intra-ocular surgery
  • Prior trauma
  • Any pre-existing iris abnormalities including pupillary deformity, posterior synechiae, peripheral anterior synechiae, zonular dehiscence
  • Pseudoexfoliation
  • Allergy to any of the mydriasis agents
  • Pregnancy or breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02909140


Locations
Layout table for location information
United States, Maryland
Wilmer Eye Institute, Johns Hopkins
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
Layout table for investigator information
Principal Investigator: Fasika Woreta, M.D., M.P.H Johns Hopkins University
  Study Documents (Full-Text)

Documents provided by Johns Hopkins University:

Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02909140     History of Changes
Other Study ID Numbers: IRB00091874
First Posted: September 21, 2016    Key Record Dates
Results First Posted: September 10, 2019
Last Update Posted: September 10, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Lens Diseases
Phenylephrine
Oxymetazoline
Cataract
Mydriasis
Eye Diseases
Pupil Disorders
Lidocaine
Epinephrine
Racepinephrine
Epinephryl borate
Cyclopentolate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents