NCT02909140

Optimal Method for Mydriasis in Cataract Surgery

Terminated NA Results posted Last updated 22 August 2019

What this trial tests

NA trial testing Topical phenylephrine 2.5% in Cataract in 3 participants. Terminated before completion.

Timeline

1 September 2016

Primary endpoint
15 August 2018

15 August 2018

Quick facts

Lead sponsor	Johns Hopkins University
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	3
Start date	1 September 2016
Primary completion	15 August 2018
Estimated completion	15 August 2018
Sites	1 location across United States

Drugs / interventions tested

• Topical phenylephrine 2.5% — full drug profile →
• Topical cyclopentolate 1% — full drug profile →
• Intracameral Lidocaine 1% — full drug profile →
• Intracameral 0.2- 0.3ml of epinephrine 1:10,000 — full drug profile →

Conditions studied

• Cataract — all drugs for Cataract →

Sponsor

Johns Hopkins University

Who can join

40 and older, any sex, with Cataract. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.