Open Angle GlaucomaPhase 3PACCTNCT04005079
Pilocarpine After Combined Cataract/Trabectome Surgery
A Phase 3 study testing Pilocarpine, Ofloxacin and Prednisolone in people with Open Angle Glaucoma and Ocular Hypertension, run by Montefiore Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Open Angle Glaucoma, Ocular Hypertension
- What is being tested?
- Pilocarpine, Ofloxacin and Prednisolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2019to 21 Jan 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with previous history of eye surgeries (including laser procedures).
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: A Prospective Randomized Control Trial of Pilocarpine Use After Combined Cataract/Trabectome Surgery
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.
Read the 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
- Open Angle Glaucoma, Ocular Hypertension
- Being tested
- Pilocarpine, Ofloxacin, Prednisolone
- Keywords
- Cataract surgery, Trabectome, Eye Surgery, Vision, Glaucoma Surgery
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PilocarpineDrug
Also called Ocu-Carpine
2% pilocarpine in the postoperative period in addition to standard postoperative drops (Prednisolone acetate and Ofloxacin)
OfloxacinDrug
Also called Ocuflox
Standard of care
PrednisoloneDrug
Also called Ocu-Pred
Standard of Care
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | 2% pilocarpine and standard of care post op drops ( Prednisolone acetate and Ofloxacin) Receives: Drug: Pilocarpine; Drug: Ofloxacin; Drug: Prednisolone |
| Control Group | Active comparator | Standard of care post op drops-Prednisolone acetate and Ofloxacin, without pilocarpine Receives: Drug: Ofloxacin; Drug: Prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of intraocular lowering from baseline
Percentage of IOP drop at 1 month, 6 months and 1 year after surgery.
Measured: 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
Measured: 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
Measured: Up to 3 years
Secondary outcomes (2)
Frequency of pilocarpine related side effects
Most common side effects will be counted - blurry vision, decrease night vision, headaches, browache, nausea, vomiting, diarrhea
Measured: Up to 3 years
Frequency of drug discontinuation due to pilocarpine related side effects
The number of drug discontinuation due to common side effects will be counted
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start5 Jun 2019
- Primary completion21 Jan 2021
- Study completion21 Jan 2021
Why it stopped: not performing Trabectomes
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Angle GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wen-Jeng (Melissa) Yao, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04005079
- Sponsor's protocol ID
- 2017-8704
- Acronym
- PACCT
- Status last verified
- Apr 2022
- First submitted
- 28 Jun 2019
- Last updated
- 7 Apr 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Control Trial of Pilocarpine Use After Combined Cataract/Trabectome Surgery
- ClinicalTrials.gov ID
- NCT04005079
- Acronym / sponsor ID
- PACCT / 2017-8704
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Keywords
- Cataract surgery, Trabectome, Eye Surgery, Vision, Glaucoma Surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: not performing Trabectomes
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- 5 Jun 2019 (actual)
- Primary completion
- 21 Jan 2021 (actual)
- Study completion
- 21 Jan 2021 (actual)
- First posted
- 2 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Drug: Pilocarpine, Drug: Ofloxacin, Drug: Prednisolone2% pilocarpine and standard of care post op drops ( Prednisolone acetate and Ofloxacin) |
| Control Group | Active comparator | Drug: Ofloxacin, Drug: PrednisoloneStandard of care post op drops-Prednisolone acetate and Ofloxacin, without pilocarpine |
Who may qualify
- Ages
- 30 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with previous history of eye surgeries (including laser procedures).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PilocarpineAlso: Ocu-Carpine2% pilocarpine in the postoperative period in addition to standard postoperative drops (Prednisolone acetate and Ofloxacin) | Drug | Treatment Group |
| OfloxacinAlso: OcufloxStandard of care | Drug | Control Group, Treatment Group |
| PrednisoloneAlso: Ocu-PredStandard of Care | Drug | Control Group, Treatment Group |
Primary outcome
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.
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
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
2 secondary outcomes
Frequency of pilocarpine related side effects
Time frame: Up to 3 years
Frequency of drug discontinuation due to pilocarpine related side effects
Time frame: Up to 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wen-Jeng (Melissa) Yao, MD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pilocarpine, Ofloxacin and Prednisolone in people with Open Angle Glaucoma and Ocular Hypertension, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of intraocular lowering from baseline (time frame: Up to 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2022.