Clinical Trial: Optimal Method for Mydriasis in Cataract Surgery

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Optimal Method for Mydriasis in Cataract Surgery

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.

Detailed Summary:

Recent research has compared the use of intracameral and topical agents with the preoperative pupil size and cataract surgery success. Studies have compared topical mydriatics with intracameral lidocaine and found no significant difference in dilation. , Other studies have compared topical mydriatics with intracameral dilation that includes solutions with and without epinephrine in the irrigating solution and concluded that irrigating solutions without epinephrine can safely be used with intracameral mydriatics but epinephrine is useful when using topical mydriatics. There have also been studies comparing the success of longer acting drug inserts of mydriatic agents with the use of intracameral agents. In addition to these standard agents, different surgeons have used various formulations of topical and intracameral agents to perform mydriasis. As of yet, there is no formal, standardized method for mydriasis and no large prospective study comparing the outcomes of the various methods. Considerations such as cost and time spent on preoperative mydriatic agents in light of the amount of success seen with these agents calls into question the need for such agents. We would like to study the amount of pupillary dilation seen with topical preoperative mydriatic agents compared to intracameral agents compared to the use of them both together.

This will be a prospective randomized controlled trial. Patients will be consented and enrolled at their pre-op visit. They will be randomized to topical drops alone, intracameral injection alone, or topical plus intracameral mydriasis. All patients will receive intracameral lidocaine, as this is used for its anesthetic effect but also has some mydriatic effect. The intervention will take place on the day of the operation. Patients will be followed until post-operative month #1.

Data will be
Sponsor: Johns Hopkins University

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Pupil size immediately after nuclear disassembly [ Time Frame: Immediately after nuclear disassembly step of cataract surgery ]
  • Pupil size immediately prior to Intraocular lens (IOL) insertion [ Time Frame: Immediately prior to IOL insertion step of cataract surgery ]
  • Pupil size upon completion of surgery [ Time Frame: intraoperative ]
  • Pupil size on post-operative Day 1 [ Time Frame: Post-operative Day 1 ]
  • Percentage of patients in each arm that required another mydriatic agent or the use of an iris expansion device during the procedure [ Time Frame: intraoperative ]
  • Mean time taken to perform phacoemulsification and cumulative energy dispersed for each arm [ Time Frame: During cataract surgery ]
  • Mean time taken to perform the cataract surgery in each arm [ Time Frame: intraoperative ]
  • Percentage of patients with an increase in the blood pressure or heart rate [ Time Frame: Baseline, intraoperative ]


Original Secondary Outcome: Same as current

Information By: Johns Hopkins University

Dates:
Date Received: September 19, 2016
Date Started: December 2016
Date Completion: August 2017
Last Updated: December 12, 2016
Last Verified: December 2016