Pupillary ConstrictionNCT07012512
Adjusted Study Protocol: Within-Subject Paired-Eye Design Comparing Pilocarpine 0.1%, Phentolamine 0.75%, and Combination Therapy for Cyclopentolate Reversal in Children
A study testing Use of phentolamine eye drops to reverse cycloplegia, Pilocarpine 0.1% and Combination of pilocarpine 0.1% and phentolamine 0.75% in people with Pupillary Constriction and Accomodation, run by Mansoura University.
Trial summary
The study aims at reversing pupillary dilatation. and cycloplegia in children undergoing cycloplegic refraction for eyeglasses prescription and ocular examination. This will be achieved using pilocarpine , phentolamine or a combination. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Pupillary Constriction, Accomodation
- What is being tested?
- Use of phentolamine eye drops to reverse cycloplegia, Pilocarpine 0.1% and Combination of pilocarpine 0.1% and phentolamine 0.75%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children between 5 and 12 years undergoing cycloplegia
Who cannot join
- Patient refusal
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The study aims at reversing pupillary dilatation. and cycloplegia in children undergoing cycloplegic refraction for eyeglasses prescription and ocular examination. This will be achieved using pilocarpine , phentolamine or a combination. This may help decrease the glare and improve near vision early to decrease unwanted effects of cycloplegic drops.
Read the detailed description
To compare the efficacy of pilocarpine 0.1%, phentolamine 0.75%, and combined therapy in reversing cyclopentolate-induced cycloplegia/mydriasis in pediatric patients using a within-subject paired-eye design (treated vs. untreated eye).
Interventions
Cycloplegia Induction:
Both eyes receive cyclopentolate 1% (2 drops, 5 minutes apart). Then cycloplegic effect confirmed at 30 minutes (accommodation ≤2 D, pupil ≥6 mm).
Reversal Agents (administered at 30 minutes post-cyclopentolate):
Pilocarpine group: Pilocarpine 0.1% (1 drop) in the study eye; placebo in the control eye.
Phentolamine group: Phentolamine 0.75% (1 drop) in the study eye; placebo in the control eye.
Combination: Pilocarpine 0.1% + phentolamine 0.75% (1 drop each) in the study eye; placebo in the control eye.
- Conditions
- Pupillary Constriction, Accomodation
- Being tested
- Use of phentolamine eye drops to reverse cycloplegia, Pilocarpine 0.1%, Combination of pilocarpine 0.1% and phentolamine 0.75%
- Medical subject headings
- Miosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of phentolamine eye drops to reverse cycloplegiaDrug
Use of phentolamine 0.75% eye drops to reverse cycloplegia
Pilocarpine 0.1%Drug
Use of pilocarpine 0.1% to reverse cycloplegia
Combination of pilocarpine 0.1% and phentolamine 0.75%Drug
Combination of pilocarpine 0.1% and phentolamine 0.75%
| Study group | Role | What they receive |
|---|---|---|
| Pilocarpine group | Experimental | Children will receive pilocarpine drops in one eye and placebo in the other Receives: Drug: Pilocarpine 0.1% |
| Phentolamine group | Active comparator | Children will receive phentolamine eye drop in one eye and placebo in the other Receives: Drug: Use of phentolamine eye drops to reverse cycloplegia |
| Combined | Experimental | Children will receive a combination of pilocarpine and placebo in one eye and placebo in the other Receives: Drug: Combination of pilocarpine 0.1% and phentolamine 0.75% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reversal of pupillary dilatation
Measured: Hourly for four hours after administration of the drug
Secondary outcomes (1)
Recovery of accommodation after instillation of the drop
Measured: Hourly for four hours after administration of the drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pupillary ConstrictionStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07012512
- Sponsor's protocol ID
- Mansoura university Ophthalmic
- Status last verified
- May 2025
- First submitted
- 30 May 2025
- Last updated
- 10 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjusted Study Protocol: Within-Subject Paired-Eye Design Comparing Pilocarpine 0.1%, Phentolamine 0.75%, and Combination Therapy for Cyclopentolate Reversal in Children
- ClinicalTrials.gov ID
- NCT07012512
- Acronym / sponsor ID
- Mansoura university Ophthalmic
- Conditions
- Pupillary Constriction, Accomodation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 10 Jun 2025 (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.
The study aims at reversing pupillary dilatation. and cycloplegia in children undergoing cycloplegic refraction for eyeglasses prescription and ocular examination. This will be achieved using pilocarpine , phentolamine or a combination. This may help decrease the glare and improve near vision early to decrease unwanted effects of cycloplegic drops.
Detailed description
To compare the efficacy of pilocarpine 0.1%, phentolamine 0.75%, and combined therapy in reversing cyclopentolate-induced cycloplegia/mydriasis in pediatric patients using a within-subject paired-eye design (treated vs. untreated eye).
Interventions
Cycloplegia Induction:
Both eyes receive cyclopentolate 1% (2 drops, 5 minutes apart). Then cycloplegic effect confirmed at 30 minutes (accommodation ≤2 D, pupil ≥6 mm).
Reversal Agents (administered at 30 minutes post-cyclopentolate):
Pilocarpine group: Pilocarpine 0.1% (1 drop) in the study eye; placebo in the control eye.
Phentolamine group: Phentolamine 0.75% (1 drop) in the study eye; placebo in the control eye.
Combination: Pilocarpine 0.1% + phentolamine 0.75% (1 drop each) in the study eye; placebo in the control eye.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pilocarpine group | Experimental | Drug: Pilocarpine 0.1%Children will receive pilocarpine drops in one eye and placebo in the other |
| Phentolamine group | Active comparator | Drug: Use of phentolamine eye drops to reverse cycloplegiaChildren will receive phentolamine eye drop in one eye and placebo in the other |
| Combined | Experimental | Drug: Combination of pilocarpine 0.1% and phentolamine 0.75%Children will receive a combination of pilocarpine and placebo in one eye and placebo in the other |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children between 5 and 12 years undergoing cycloplegia
Key exclusion criteria (1 listed)
- Patient refusal
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 |
|---|---|---|
| Use of phentolamine eye drops to reverse cycloplegiaUse of phentolamine 0.75% eye drops to reverse cycloplegia | Drug | Phentolamine group |
| Pilocarpine 0.1%Use of pilocarpine 0.1% to reverse cycloplegia | Drug | Pilocarpine group |
| Combination of pilocarpine 0.1% and phentolamine 0.75%Combination of pilocarpine 0.1% and phentolamine 0.75% | Drug | Combined |
Primary outcome
Reversal of pupillary dilatation
Time frame: Hourly for four hours after administration of the drug
1 secondary outcome
Recovery of accommodation after instillation of the drop
Time frame: Hourly for four hours after administration of the drug
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Use of phentolamine eye drops to reverse cycloplegia, Pilocarpine 0.1% and Combination of pilocarpine 0.1% and phentolamine 0.75% in people with Pupillary Constriction and Accomodation, run by Mansoura University.
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 1 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: opening soon, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed AlNagdy (+201096710982, imanatta@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reversal of pupillary dilatation (time frame: Hourly for four hours after administration of the drug). 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 10 Jun 2025.