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Pilocarpine After Combined Cataract/Trabectome Surgery (PACCT)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04005079
Recruitment Status : Recruiting
First Posted : July 2, 2019
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
Melissa Wen-Jeng Yao, Montefiore Medical Center

Brief Summary:
Combined cataract + trabectome surgery is a surgery designed to help lower the intraocular pressure (pressure in the eye) and hopefully reduce the need for topical drops, progression of glaucoma, and/or further glaucoma surgeries. The purpose of this study is to assess whether using pilocarpine, a medication which is FDA approved to induce miosis, (in other words cause the pupil to constrict or become smaller) provides additional benefit to the success of Trabectome and cataract surgery.

Condition or disease Intervention/treatment Phase
Open Angle Glaucoma Ocular Hypertension Drug: Pilocarpine Drug: Ofloxacin Drug: Prednisolone Phase 3

Detailed Description:

Glaucoma is the leading cause of irreversible blindness worldwide, and its treatment consists of lowering intraocular pressure (IOP) to prevent damage to the optic nerve and loss of vision. Microincisional glaucoma surgery (MIGS) have become more popular in recent years as less invasive methods than traditional surgeries that effectively reduce IOP and help reduce the medication burden on patients.There are multiple available MIGS procedures, most of which act by increasing trabecular outflow. One such procedure is the Trabectome, which is usually performed in combination with cataract surgery.

Trabectome is an FDA approved device used to perform a trabeculectomy via an internal approach. A strip of 60-120 degrees of the nasal angle trabecular meshwork and the inner wall of Schlemm's canal are removed providing a direct pathway for aqueous outflow from the anterior chamber into the collector channels[2].

Pilocarpine, a parasympathomimetic agent, is a glaucoma medication that works by causing contraction of the ciliary muscle leading to opening of the trabecular meshwork[3]. Due to its frequent dosing requirement and large number of ocular and systemic side effects, pilocarpine has largely fallen out of favor for the treatment of primary open angle glaucoma (POAG), except in patients for whom few other alternatives exist. However, pilocarpine is often used after trabectome surgery.

The rationale for its use after Trabectome procedure is for its miotic effect, which theoretically may prevent the formation of peripheral anterior synechiae. Formation of peripheral anterior synechiae can lead to the closure of the cleft that is generated and the possibility of failure of the procedure. While the theoretical benefit of pilocarpine has been proposed, its actual benefit has never been proven.

In this study, the aim is to evaluate whether Trabecome / Cataract surgery without pilocarpine is non-inferior to Trabecome / Cataract surgery procedure followed by treatment with pilocarpine

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The "Treatment Group" will use 2% pilocarpine in the postoperative period in addition to standard post-operative drops (Prednisolone acetate and Ofloxacin). The "Control Group" will use only Prednisolone acetate and Ofloxacin, without pilocarpine.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Control Trial of Pilocarpine Use After Combined Cataract/Trabectome Surgery
Actual Study Start Date : June 5, 2019
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2029


Arm Intervention/treatment
Experimental: Treatment Group
2% pilocarpine and standard of care post op drops ( Prednisolone acetate and Ofloxacin)
Drug: Pilocarpine
2% pilocarpine in the postoperative period in addition to standard postoperative drops (Prednisolone acetate and Ofloxacin)

Drug: Ofloxacin
Standard of care

Drug: Prednisolone
Standard of Care

Active Comparator: Control Group
Standard of care post op drops-Prednisolone acetate and Ofloxacin, without pilocarpine
Drug: Ofloxacin
Standard of care

Drug: Prednisolone
Standard of Care




Primary Outcome Measures :
  1. Percentage of intraocular lowering from baseline [ Time Frame: Up to 1 year ]
    Percentage of IOP drop at 1 month, 6 months and 1 year after surgery.

  2. Number of IOP lowering agents required to achieve goal IOP [ Time Frame: Up to 3 years ]
    The number of pre and post procedure drops required to achieve goal IOP at 6 months, 1, 2 and 3 years after combined cataract/trabectome surgery in patients treated with post-op pilocarpine vs control

  3. Rate of progression to further glaucoma surgeries. [ Time Frame: Up to 3 years ]
    Assessment of the rate of progression towards further surgery in patients treated with post-op pilocarpine vs control over a 3 year follow up period


Secondary Outcome Measures :
  1. Frequency of pilocarpine related side effects [ Time Frame: Up to 3 years ]
  2. Frequency of drug discontinuation due to pilocarpine related side effects [ Time Frame: Up to 3 years ]


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Ages Eligible for Study:   30 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age Range: 30 to 100 years old
  • Patients with ocular hypertension or open angle glaucoma undergoing combined cataract surgery with trabectome in a single surgical center

Exclusion Criteria:

  • Patients with previous history of eye surgeries (including laser procedures).

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): NCT04005079


Contacts
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Contact: Wen-Jeng (Melissa) Yao, MD 718-920-2020 WYAO@montefiore.org

Locations
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United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Wen-Jeng (Melissa) Yao, MD         
Principal Investigator: Wen-Jeng (Melissa) Yao, MD         
Sponsors and Collaborators
Montefiore Medical Center
Investigators
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Principal Investigator: Wen-Jeng (Melissa) Yao, MD Montefiore Medical Center
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Responsible Party: Melissa Wen-Jeng Yao, Professor of Ophthalmology and Visual Services, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT04005079    
Other Study ID Numbers: 2017-8704
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Melissa Wen-Jeng Yao, Montefiore Medical Center:
Cataract surgery
Trabectome
Eye Surgery
Vision
Glaucoma Surgery
Additional relevant MeSH terms:
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Glaucoma
Cataract
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Lens Diseases
Ofloxacin
Prednisolone
Pilocarpine
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Autonomic Agents
Peripheral Nervous System Agents
Miotics
Muscarinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors