PresbyopiaPhase 3NCT05578001
Efficacy of Pilocarpine 1% in Presbyopia
A Phase 3 study testing Pilocarpine Ophthalmic in people with Presbyopia and Pseudophakia, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial summary
In this before-after interventional study on patients with presbyopia after cataract surgery, uncorrected distance vision and corrected distance visual acuity are measured and recorded by Snellen chart. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Presbyopia, Pseudophakia
- What is being tested?
- Pilocarpine Ophthalmic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteIran
- Study dates
- 1 Jul 2022to 30 Mar 2023
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Informed consent to participate in the study
- Previous uncomplicated cartaract surgery and PCIOL insertion
- BCDVA eqaul to or more than 8/10
- Less than 1.5 diopter cylindrical refractive error
- Spherical refractive error between -0.5_+1.5
- No history of previous eye disease
- Not using drugs that interact with pilocarpine
Who cannot join
- Occurrence of any drug-related complications
- Unable to follow up the patient after prescribing the drug
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Pilocarpine 1% in Pseudophakia Individuals With Presbyopia
In this before-after interventional study on patients with presbyopia after cataract surgery, uncorrected distance vision and corrected distance visual acuity are measured and recorded by Snellen chart. Corrected near visual acuity from a distance of 40 cm is measured by the standard near vision chart (Rosenbaum near vision card). Twenty minutes after the administration of pilocarpine 1%, the corrected near and far visual acuity is measured again. Also, the relationship between the difference in average near visual acuity after the administration of 1% pilocarpine in pseudophakic people is measured with iris color and pupil size.
Read the detailed description
After selecting the study cases, the pupil size in both photopic and scotopic conditions and iris color(based on Simionescu's classification) will be recorded. Uncorrected distance visual acuity(UCDVA) will be measured by Snellen chart. Then the appropriate glasses will be placed according to the person's refraction and the corrected distance visual acuity(BCDVA) will be measured. Without changing the fitted glasses, corrected near visual acuity(BCNVA) is measured from a distance of 40 cm by the standard near vision chart (Rosenbaum near vision card). After this stage, one drop of pilocarpine 1% is prescribed in the patient's eye and 20 minutes later, the corrected near and far visual acuity is measured again. Thirty minutes and 8 hours after the administration of pilocarpine drop, the side effects of the drug, including headache, eye pain, eye redness, eye irritation, tearing, and blurred vision at night, are checked.
- Conditions
- Presbyopia, Pseudophakia
- Being tested
- Pilocarpine Ophthalmic
- Keywords
- Pilocarpine, Presbyopia, Pseudophakia
- Medical subject headings
- Presbyopia, Pseudophakia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilocarpine OphthalmicDrug
Also called Glaupin 1%
1 drop of Pilocarpine 1%
| Study group | Role | What they receive |
|---|---|---|
| Pilocarpine | Experimental | 1 drop of Pilocarpine 1% instill in the eye Receives: Drug: Pilocarpine Ophthalmic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Corrected Near Visual Acuity
Comparison of the BCNVA before and after instillation of Pilocarpine 1%
Measured: 20 minutes
Secondary outcomes (1)
Best Corrected Distance Visual Acuity
Comparison of the BCDVA before and after instillation of Pilocarpine 1%
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start1 Jul 2022
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PresbyopiaStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alireza Peyman, Isfahan University of Medical Sciences
- Investigators
- Alireza Peyman, M.D., Study chair, Isfahan University of Medical Sciences, Isfahan, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05578001
- Sponsor's protocol ID
- IR.MUI.MED.REC.1401.184
- Status last verified
- Oct 2022
- First submitted
- 10 Oct 2022
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Peyman A, Naderi-Lordejani M, Irajpour M, Ghanbarnia MJ, Koosha N, Pourazizi M. Pilocarpine 1% for Improved Near Vision in Pseudophakic Patients. J Ophthalmic Vis Res. 2025 May 19;20:10.18502/jovr.v20.15331. doi: 10.18502/jovr.v20.15331. eCollection 2025.
PubMed 40689127
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Pilocarpine 1% in Pseudophakia Individuals With Presbyopia
- ClinicalTrials.gov ID
- NCT05578001
- Acronym / sponsor ID
- IR.MUI.MED.REC.1401.184
- Conditions
- Presbyopia, Pseudophakia
- Keywords
- Pilocarpine, Presbyopia, Pseudophakia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Mar 2023 (estimated)
- First posted
- 13 Oct 2022 (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.
In this before-after interventional study on patients with presbyopia after cataract surgery, uncorrected distance vision and corrected distance visual acuity are measured and recorded by Snellen chart. Corrected near visual acuity from a distance of 40 cm is measured by the standard near vision chart (Rosenbaum near vision card). Twenty minutes after the administration of pilocarpine 1%, the corrected near and far visual acuity is measured again. Also, the relationship between the difference in average near visual acuity after the administration of 1% pilocarpine in pseudophakic people is measured with iris color and pupil size.
Detailed description
After selecting the study cases, the pupil size in both photopic and scotopic conditions and iris color(based on Simionescu's classification) will be recorded. Uncorrected distance visual acuity(UCDVA) will be measured by Snellen chart. Then the appropriate glasses will be placed according to the person's refraction and the corrected distance visual acuity(BCDVA) will be measured. Without changing the fitted glasses, corrected near visual acuity(BCNVA) is measured from a distance of 40 cm by the standard near vision chart (Rosenbaum near vision card). After this stage, one drop of pilocarpine 1% is prescribed in the patient's eye and 20 minutes later, the corrected near and far visual acuity is measured again. Thirty minutes and 8 hours after the administration of pilocarpine drop, the side effects of the drug, including headache, eye pain, eye redness, eye irritation, tearing, and blurred vision at night, are checked.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pilocarpine | Experimental | Drug: Pilocarpine Ophthalmic1 drop of Pilocarpine 1% instill in the eye |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Informed consent to participate in the study
- Previous uncomplicated cartaract surgery and PCIOL insertion
- BCDVA eqaul to or more than 8/10
- Less than 1.5 diopter cylindrical refractive error
- Spherical refractive error between -0.5_+1.5
Key exclusion criteria (2 listed)
- Occurrence of any drug-related complications
- Unable to follow up the patient after prescribing the drug
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 |
|---|---|---|
| Pilocarpine OphthalmicAlso: Glaupin 1%1 drop of Pilocarpine 1% | Drug | Pilocarpine |
Primary outcome
Best Corrected Near Visual Acuity
Time frame: 20 minutes
Comparison of the BCNVA before and after instillation of Pilocarpine 1%
1 secondary outcome
Best Corrected Distance Visual Acuity
Time frame: 20 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Derived from this study: PubMed 40689127Peyman A, Naderi-Lordejani M, Irajpour M, Ghanbarnia MJ, Koosha N, Pourazizi M. Pilocarpine 1% for Improved Near Vision in Pseudophakic Patients. J Ophthalmic Vis Res. 2025 May 19;20:10.18502/jovr.v20.15331. doi: 10.18502/jovr.v20.15331. eCollection 2025.
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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.
Alireza Peyman, M.D. study chair
Isfahan University of Medical Sciences, Isfahan, Iran
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 Ophthalmic in people with Presbyopia and Pseudophakia, run by Isfahan University of Medical Sciences at 1 site in Iran.
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 7 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 13 Oct 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 Iran. 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?
Results are not available in the source record.
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?
Best Corrected Near Visual Acuity (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05578001, which also lists 1 linked publication.
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 13 Oct 2022.