## Protocol Section
### Identification Module
**NCT ID:** NCT04005079

**Acronym:** PACCT

**Brief Title:** Pilocarpine After Combined Cataract/Trabectome Surgery

**Official Title:** A Prospective Randomized Control Trial of Pilocarpine Use After Combined Cataract/Trabectome Surgery

#### Organization Study ID Info
**ID:** 2017-8704
#### Organization
**Class:** OTHER
**Full Name:** Montefiore Medical Center
### Status Module
#### Completion Date
**Date:** 2021-01-21

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-04-07

**Type:** ACTUAL

**Last Update Submit Date:** 2022-04-06

**Overall Status:** WITHDRAWN

#### Primary Completion Date
**Date:** 2021-01-21

**Type:** ACTUAL

#### Start Date
**Date:** 2019-06-05

**Type:** ACTUAL

**Status Verified Date:** 2022-04

#### Study First Post Date
**Date:** 2019-07-02
**Type:** ACTUAL
**Study First Submit Date:** 2019-06-28
**Study First Submit QC Date:** 2019-06-28
**Why Stopped:** not performing Trabectomes
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Montefiore Medical Center

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Is US Export:** True

### Description Module

**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.

**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

### Conditions Module

**Conditions:**

- Open Angle Glaucoma

- Ocular Hypertension

**Keywords:**

- Cataract surgery

- Trabectome

- Eye Surgery

- Vision

- Glaucoma Surgery

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**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 Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 2% pilocarpine and standard of care post op drops ( Prednisolone acetate and Ofloxacin)

**Intervention Names:**

- Drug: Pilocarpine

- Drug: Ofloxacin

- Drug: Prednisolone

**Label:** Treatment Group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Standard of care post op drops-Prednisolone acetate and Ofloxacin, without pilocarpine

**Intervention Names:**

- Drug: Ofloxacin

- Drug: Prednisolone

**Label:** Control Group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Treatment Group

**Description:** 2% pilocarpine in the postoperative period in addition to standard postoperative drops (Prednisolone acetate and Ofloxacin)

**Name:** Pilocarpine

**Other Names:**

- Ocu-Carpine

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Control Group

- Treatment Group

**Description:** Standard of care

**Name:** Ofloxacin

**Other Names:**

- Ocuflox

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Control Group

- Treatment Group

**Description:** Standard of Care

**Name:** Prednisolone

**Other Names:**

- Ocu-Pred

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Percentage of IOP drop at 1 month, 6 months and 1 year after surgery.

**Measure:** Percentage of intraocular lowering from baseline

**Time Frame:** Up to 1 year

**Description:** 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

**Measure:** Number of IOP lowering agents required to achieve goal IOP

**Time Frame:** Up to 3 years

**Description:** 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

**Measure:** Rate of progression to further glaucoma surgeries.

**Time Frame:** Up to 3 years

#### Secondary Outcomes

**Description:** Most common side effects will be counted - blurry vision, decrease night vision, headaches, browache, nausea, vomiting, diarrhea

**Measure:** Frequency of pilocarpine related side effects

**Time Frame:** Up to 3 years

**Description:** The number of drug discontinuation due to common side effects will be counted

**Measure:** Frequency of drug discontinuation due to pilocarpine related side effects

**Time Frame:** Up to 3 years

### Eligibility Module

**Eligibility 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).

**Healthy Volunteers:** True

**Maximum Age:** 100 Years

**Minimum Age:** 30 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Bronx

**Country:** United States

**Facility:** Montefiore Medical Center

**State:** New York

**Zip:** 10467

#### Overall Officials

**Official 1:**

**Affiliation:** Montefiore Medical Center

**Name:** Wen-Jeng (Melissa) Yao, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Document Section

### Large Document Module

#### Large Docs

- Date: 2018-11-13

- Filename: Prot_SAP_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan

- Size: 137456

- Type Abbrev: Prot_SAP

- Upload Date: 2021-08-11T08:56

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005128

- Term: Eye Diseases

- ID: D000007905

- Term: Lens Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC11

- Name: Eye Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC14

- Name: Heart and Blood Diseases

### Condition Browse Module - Browse Leaves

- ID: M5638

- Name: Cataract

- Relevance: HIGH

- As Found: Cataract

- ID: M10024

- Name: Hypertension

- Relevance: LOW

- As Found: Unknown

- ID: M9013

- Name: Glaucoma

- Relevance: HIGH

- As Found: Glaucoma

- ID: M9014

- Name: Glaucoma, Open-Angle

- Relevance: HIGH

- As Found: Open Angle Glaucoma

- ID: M12731

- Name: Ocular Hypertension

- Relevance: HIGH

- As Found: Ocular Hypertension

- ID: M8271

- Name: Eye Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10917

- Name: Lens Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000005901

- Term: Glaucoma

- ID: D000002386

- Term: Cataract

- ID: D000005902

- Term: Glaucoma, Open-Angle

- ID: D000009798

- Term: Ocular Hypertension

### Intervention Browse Module - Ancestors

- ID: D000000893

- Term: Anti-Inflammatory Agents

- ID: D000005938

- Term: Glucocorticoids

- ID: D000006728

- Term: Hormones

- ID: D000006730

- Term: Hormones, Hormone Substitutes, and Hormone Antagonists

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000018931

- Term: Antineoplastic Agents, Hormonal

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000001337

- Term: Autonomic Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000008916

- Term: Miotics

- ID: D000018721

- Term: Muscarinic Agonists

- ID: D000018679

- Term: Cholinergic Agonists

- ID: D000018678

- Term: Cholinergic Agents

- ID: D000018377

- Term: Neurotransmitter Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000000892

- Term: Anti-Infective Agents, Urinary

- ID: D000000890

- Term: Anti-Infective Agents

- ID: D000000900

- Term: Anti-Bacterial Agents

- ID: D000059005

- Term: Topoisomerase II Inhibitors

- ID: D000059003

- Term: Topoisomerase Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000065609

- Term: Cytochrome P-450 CYP1A2 Inhibitors

- ID: D000065607

- Term: Cytochrome P-450 Enzyme Inhibitors

### Intervention Browse Module - Browse Branches

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: AnEm

- Name: Antiemetics

- Abbrev: NeuroAg

- Name: Neuroprotective Agents

- Abbrev: Gast

- Name: Gastrointestinal Agents

### Intervention Browse Module - Browse Leaves

- ID: M14120

- Name: Prednisolone

- Relevance: HIGH

- As Found: Vein

- ID: M30370

- Name: Levofloxacin

- Relevance: LOW

- As Found: Unknown

- ID: M17946

- Name: Ofloxacin

- Relevance: HIGH

- As Found: Histopathology

- ID: M11749

- Name: Methylprednisolone

- Relevance: LOW

- As Found: Unknown

- ID: M1833

- Name: Methylprednisolone Acetate

- Relevance: LOW

- As Found: Unknown

- ID: M11750

- Name: Methylprednisolone Hemisuccinate

- Relevance: LOW

- As Found: Unknown

- ID: M229449

- Name: Prednisolone acetate

- Relevance: LOW

- As Found: Unknown

- ID: M211887

- Name: Prednisolone hemisuccinate

- Relevance: LOW

- As Found: Unknown

- ID: M248881

- Name: Prednisolone phosphate

- Relevance: LOW

- As Found: Unknown

- ID: M13757

- Name: Pilocarpine

- Relevance: HIGH

- As Found: Motivational interview

- ID: M4217

- Name: Anti-Inflammatory Agents

- Relevance: LOW

- As Found: Unknown

- ID: M9047

- Name: Glucocorticoids

- Relevance: LOW

- As Found: Unknown

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M9788

- Name: Hormone Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M20966

- Name: Antineoplastic Agents, Hormonal

- Relevance: LOW

- As Found: Unknown

- ID: M20795

- Name: Muscarinic Agonists

- Relevance: LOW

- As Found: Unknown

- ID: M20758

- Name: Cholinergic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4222

- Name: Anti-Bacterial Agents

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M30537

- Name: Cytochrome P-450 Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000015242

- Term: Ofloxacin

- ID: D000011239

- Term: Prednisolone

- ID: D000010862

- Term: Pilocarpine

### Misc Info Module

- Version Holder: 2024-05-24
