Optimal Method for Mydriasis in Cataract Surgery

NCT02909140 | Terminated Results

• 1 other identifier: IRB00091874
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

• Pupil Size Immediately Prior to Capsulorrhexis

  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.

  Immediately prior to the capsulorrhexis step of cataract surgery

Secondary Outcomes (11)

• Pupil Size (mm) Immediately After Nuclear Disassembly

  Immediately after nuclear disassembly step of cataract surgery

• Pupil Size Immediately Prior to Intraocular Lens (IOL) Insertion

  Immediately prior to IOL insertion step of cataract surgery

• Pupil Size Upon Completion of Surgery

  intraoperative

• Pupil Size on Post-operative Day 1

  Post-operative Day 1

• Percentage of Patients in Each Arm That Required Another Mydriatic Agent

  intraoperative

Study Arms (3)

Topical Mydriasis

EXPERIMENTAL

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%

Intracameral Mydriasis

EXPERIMENTAL

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

Topical + Intracameral mydriasis

EXPERIMENTAL

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

Interventions

Topical phenylephrine 2.5% DRUG

Topical + Intracameral mydriasis; Topical Mydriasis

Topical cyclopentolate 1% DRUG

Topical + Intracameral mydriasis; Topical Mydriasis

Intracameral Lidocaine 1% DRUG

Intracameral Mydriasis; Topical + Intracameral mydriasis; Topical Mydriasis

Intracameral 0.2- 0.3ml of epinephrine 1:10,000 DRUG

Intracameral Mydriasis; Topical + Intracameral mydriasis

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Wilmer Eye Institute, Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Cataract

Interventions

Epinephrine

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Dr. Fasika Woreta
• Organization: Wilmer Eye Institute

fworeta1@jhmi.edu

(410) 955-5650

Study Officials

• Fasika Woreta, M.D., M.P.H

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2016
• First Posted: September 21, 2016
• Study Start: September 1, 2016
• Primary Completion: August 15, 2018
• Study Completion: August 15, 2018
• Last Updated: September 10, 2019
• Results First Posted: September 10, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)