Pilocarpine After Combined Cataract/Trabectome Surgery

NCT04005079 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: 2017-8704
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Open Angle Glaucoma; Ocular Hypertension

Keywords

Cataract surgery; Trabectome; Eye Surgery; Vision; Glaucoma Surgery

Outcome Measures

Primary Outcomes (3)

• Percentage of intraocular lowering from baseline

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

  Up to 1 year

• Number of IOP lowering agents required to achieve goal IOP

  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

  Up to 3 years

• Rate of progression to further glaucoma surgeries.

  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

  Up to 3 years

Secondary Outcomes (2)

• Frequency of pilocarpine related side effects

  Up to 3 years

• Frequency of drug discontinuation due to pilocarpine related side effects

  Up to 3 years

Study Arms (2)

Treatment Group

EXPERIMENTAL

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

Drug: Pilocarpine; Drug: Ofloxacin; Drug: Prednisolone

Control Group

ACTIVE COMPARATOR

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

Drug: Ofloxacin; Drug: Prednisolone

Interventions

Pilocarpine DRUG

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

Also known as: Ocu-Carpine

Treatment Group

Ofloxacin DRUG

Standard of care

Also known as: Ocuflox

Control Group; Treatment Group

Prednisolone DRUG

Standard of Care

Also known as: Ocu-Pred

Control Group; Treatment Group

Eligibility Criteria

• Age: 30 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

Pilocarpine; Ofloxacin; Prednisolone; Methylprednisolone

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Wen-Jeng (Melissa) Yao, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 28, 2019
• First Posted: July 2, 2019
• Study Start: June 5, 2019
• Primary Completion: January 21, 2021
• Study Completion: January 21, 2021
• Last Updated: April 7, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)