Diabetes (DM)NCT07495670

Comparison of 4 Methods of Eye Drops for Pupil Dilation in Diabetic Patients

A study testing 1 drop of a 0.8% tropicamide + 5% phenylephrine combination, 1 drop of 0.5% tetracaine and 1 drop of a 0.8% tropicamide + 5% phenylephrine combination and 3 drops of a 0.8% tropicamide + 5% phenylephrine combination in people with Diabetes (DM) and Retinopathy, Diabetic, run by Burapha University at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Pupil dilation is required for many eye conditions. Diabetic patients may need more dilating eye drops to have pupil size large enough for eye exams. This study compares 4 methods of eye drops for pupil dilation in diabetic patients scheduled for retinopathy screening. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes (DM), Retinopathy, Diabetic, Pupil Dilation
What is being tested?: 1 drop of a 0.8% tropicamide + 5% phenylephrine combination, 1 drop of 0.5% tetracaine and 1 drop of a 0.8% tropicamide + 5% phenylephrine combination and 3 drops of a 0.8% tropicamide + 5% phenylephrine combination
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 84 participants
Where: 1 siteThailand
Study dates: 4 Nov 2024to 31 Jan 2025
Phase: Interventional
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diabetic patients who were scheduled for diabetic retinopathy screening at OPD eye
Age 18 years or older

Who cannot join

Conditions potentially affecting pupillary reaction (e.g., history of uveitis, previous intraocular surgery, posterior synechiae)
Known allergies to the study medications
Systolic blood pressure > 160 mmHg
Diastolic blood pressure > 100 mmHg
Pulse rate > 100 beats/min

Trial locations and contacts

1 site in 1 country.

Thailand1 site

Burapha University
Chon Buri, 20131

Other trials in Thailand

About this study

Official title: Comparison of Mydriatic Effects Between 4 Regimens of a Tropicamide-Phenylephrine Combination in Diabetic Patients

Read the detailed description

Diabetic patients participating in this study will be randomed to get 1 drop or 3 drops of dilating drug. And one eye of each patient will be randomed to get 1 drop of anesthetics, while the other eye does not. So there are 4 groups of eyes in the study. Group 1 receive 1 drop of dilating drug. Group 2 receive 1 drop of anesthetics + 1 drop of dilating drug. Group 3 receive 3 drops of dilating drug. And group 4 receive 1 drop of anesthetics + 3 drops of dilating drug. Pupil size will be measured before and after the drops.

Conditions: Diabetes (DM), Retinopathy, Diabetic, Pupil Dilation
Being tested: 1 drop of a 0.8% tropicamide + 5% phenylephrine combination, 1 drop of 0.5% tetracaine and 1 drop of a 0.8% tropicamide + 5% phenylephrine combination, 3 drops of a 0.8% tropicamide + 5% phenylephrine combination, 1 drop of 0.5% tetracaine and 3 drops of a 0.8% tropicamide + 5% phenylephrine combination
Keywords: Pupil, Dilatation, Administration, Topical, Anesthetics, Retinopathy, Diabetic
Medical subject headings: Diabetes Mellitus, Diabetic Retinopathy, Mydriasis, Dilatation, Pathologic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

1 drop of a 0.8% tropicamide + 5% phenylephrine combinationDrug
1 drop of a 0.8% tropicamide (muscarinic antagonist) + 5% phenylephrine (α1-adrenergic agonist) combination
1 drop of 0.5% tetracaine and 1 drop of a 0.8% tropicamide + 5% phenylephrine combinationDrug
1 drop of 0.5% tetracaine (anesthetics) and 1 drop of a 0.8% tropicamide (muscarinic antagonist) + 5% phenylephrine (α1-adrenergic agonist) combination
3 drops of a 0.8% tropicamide + 5% phenylephrine combinationDrug
3 drops of a 0.8% tropicamide (muscarinic antagonist) + 5% phenylephrine (α1-adrenergic agonist) combination
1 drop of 0.5% tetracaine and 3 drops of a 0.8% tropicamide + 5% phenylephrine combinationDrug
1 drop of 0.5% tetracaine (anesthetics) and 3 drops of a 0.8% tropicamide (muscarinic antagonist) + 5% phenylephrine (α1-adrenergic agonist) combination

Study groups in NCT07495670
Study group	Role	What they receive
1 drop	Experimental	1 drop of a 0.8% tropicamide - 5% phenylephrine combination Receives: Drug: 1 drop of a 0.8% tropicamide + 5% phenylephrine combination
2 drops	Experimental	1 drop of tetracaine and 1 drop of a 0.8% tropicamide - 5% phenylephrine combination Receives: Drug: 1 drop of 0.5% tetracaine and 1 drop of a 0.8% tropicamide + 5% phenylephrine combination
3 drops	Experimental	3 drops of a 0.8% tropicamide - 5% phenylephrine combination Receives: Drug: 3 drops of a 0.8% tropicamide + 5% phenylephrine combination
4 drops	Experimental	1 drop of tetracaine and 3 drops of a 0.8% tropicamide - 5% phenylephrine combination Receives: Drug: 1 drop of 0.5% tetracaine and 3 drops of a 0.8% tropicamide + 5% phenylephrine combination

What is being measured

The primary outcome is the main question the study is designed to answer.

Pupillary size
Measurement of pupillary size in millimeters (at baseline, then every 10 minutes)
Measured: 30 minutes

Secondary outcomes (4)

Systolic blood pressure
Measurement of systolic blood pressure (at baseline, then every 10 minutes)
Measured: 30 minutes
Diastolic blood pressure
Measurement of diastolic blood pressure (at baseline, then every 10 minutes)
Measured: 30 minutes
Pulse rate
Measurement of pulse rate (at baseline, then every 10 minutes)
Measured: 30 minutes
Ocular discomfort
Patients report of ocular discomfort during topical administration and the measurement of pupillary size in pain score (0-10)
Measured: When all measurements concluded (at minute 30)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Nov 202431 Jan 2025

First posted27 Mar 2026
Study start4 Nov 2024
Primary completion31 Jan 2025
Study completion31 Jan 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (23)Papers the sponsor has linked to this study.
Other trials for Diabetes (DM)Studies 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: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Care provider, Outcomes assessor
Enrolment: 84 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07495670
Sponsor's protocol ID: IRB1-052/2567
Status last verified: Mar 2026
First submitted: 19 Mar 2026
Last updated: 27 Mar 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: IPD used in the results publication

Publications

Bhatia J, Varghese M, Bhatia A. Effect of 10% phenylephrine eye drops on systemic blood pressure in normotensive & hypertensive patient. Oman Med J. 2009 Jan;24(1):30-2. doi: 10.5001/omj.2009.8.
PubMed 22303506
Kenawy NB, Jabir M. Phenylephrine 2.5% and 10% in phacoemulsification under topical anaesthesia: is there an effect on systemic blood pressure? Br J Ophthalmol. 2003 Apr;87(4):505-6. doi: 10.1136/bjo.87.4.505. No abstract available.
PubMed 12642324
Chin KW, Law NM, Chin MK. Phenylephrine eye drops in ophthalmic surgery--a clinical study on cardiovascular effects. Med J Malaysia. 1994 Jun;49(2):158-63.
PubMed 8090095
Brown MM, Brown GC, Spaeth GL. Lack of side effects from topically administered 10% phenylephrine eyedrops. A controlled study. Arch Ophthalmol. 1980 Mar;98(3):487-9. doi: 10.1001/archopht.1980.01020030483009.
PubMed 7362505
Leopold IH. The phenylephrine saga--a drug dilemma. Am J Ophthalmol. 1978 Apr;85(4):572-4. doi: 10.1016/s0002-9394(14)75261-4. No abstract available.
PubMed 655237
Motta MM, Coblentz J, Fernandes BF, Burnier MN Jr. Mydriatic and cardiovascular effects of phenylephrine 2.5% versus phenylephrine 10%, both associated with tropicamide 1%. Ophthalmic Res. 2009;42(2):87-9. doi: 10.1159/000220601. Epub 2009 May 27.
PubMed 19478547
Shrivastava AK, Nayak S, Anto M. Efficacy of Nepafenac versus Flurbiprofen in Maintaining Intraoperative Mydriasis During Phacoemulsification: A Comparative Study. Clin Ophthalmol. 2021 Mar 9;15:1085-1093. doi: 10.2147/OPTH.S303480. eCollection 2021.
PubMed 33727791
Kergoat H, Lovasik JV, Doughty MJ. A pupillographic evaluation of a phenylephrine HCl 5%-tropicamide 0.8% combination mydriatic. J Ocul Pharmacol. 1989 Fall;5(3):199-216. doi: 10.1089/jop.1989.5.199.
PubMed 2625616
Trinavarat A, Pituksung A. Effective pupil dilatation with a mixture of 0.75% tropicamide and 2.5% phenylephrine: A randomized controlled trial. Indian J Ophthalmol. 2009 Sep-Oct;57(5):351-4. doi: 10.4103/0301-4738.55070.
PubMed 19700872
Pollack SL, Hunt JS, Polse KA. Dose-response effects of tropicamide HCl. Am J Optom Physiol Opt. 1981 May;58(5):361-6. doi: 10.1097/00006324-198105000-00003.
PubMed 7258285
Sinclair SH, Pelham V, Giovanoni R, Regan CD. Mydriatic solution for outpatient indirect ophthalmoscopy. Arch Ophthalmol. 1980 Sep;98(9):1572-4. doi: 10.1001/archopht.1980.01020040424004.
PubMed 7425917
Bhurayanontachai P, Saengkaew S, Apiromruck P. Efficacy of an eye drop mixture for pupillary dilatation: A randomized comparative study. J Optom. 2017 Apr-Jun;10(2):111-116. doi: 10.1016/j.optom.2016.04.007. Epub 2016 Jun 16.
PubMed 27321772
Park JH, Lee YC, Lee SY. The comparison of mydriatic effect between two drugs of different mechanism. Korean J Ophthalmol. 2009 Mar;23(1):40-2. doi: 10.3341/kjo.2009.23.1.40. Epub 2009 Mar 9.
PubMed 19337478
Ghose S, Garodia VK, Sachdev MS, Kumar H, Biswas NR, Pandey RM. Evaluation of potentiating effect of a drop of lignocaine on tropicamide-induced mydriasis. Invest Ophthalmol Vis Sci. 2001 Jun;42(7):1581-5.
PubMed 11381064
Apt L, Henrick A. Pupillary dilatation with single eyedrop mydriatic combinations. Am J Ophthalmol. 1980 Apr;89(4):553-9. doi: 10.1016/0002-9394(80)90065-3.
PubMed 7369319

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
A Novel Miniature Equine-Assisted Diabetes Education Program for Youth: Evaluating the Diabetes Equine Empowerment Program (DEEP).
Diabetes (Insulin-requiring, Type 1 or Type 2), Pediatric Diabetes
Recruiting
Continuous Monitoring of Plantar Temperature Variations Using Connected Insoles and a Mobile Application for Diabetic Foot.
Diabetic Foot Disease, Diabetic Foot Infection
Enrolling by invitationObservational study
Personalizing A1c Using Hematologic Indices and CGM for Accurate Diabetes Diagnosis
Type 2 Diabetes
Active, not recruitingObservational study
Evaluation of MTHFR and DNMT3B Gene Polymorphisms Along With Periodontal Clinical Parameters in Healthy Individuals and Individuals With Type 2 Diabetes and Periodontitis
Periodontitis, Type 2 Diabetes Mellitus (DM)
RecruitingObservational study
Dietitian-Nutritionist vs. Day Hospital in the Metabolic Control of Patients With Type 2 Diabetes
Diabetes (DM)

All Diabetes (DM) trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Mydriatic Effects Between 4 Regimens of a Tropicamide-Phenylephrine Combination in Diabetic Patients
ClinicalTrials.gov ID: NCT07495670
Acronym / sponsor ID: IRB1-052/2567
Conditions: Diabetes (DM), Retinopathy, Diabetic, Pupil Dilation
Keywords: Pupil, Dilatation, Administration, Topical, Anesthetics, Retinopathy, Diabetic
Study type: Interventional
Recruitment status: Completed
Enrolment: 84 participants (actual)
Lead sponsor: Burapha UniversityUniversity, hospital or other
Study start: 4 Nov 2024 (actual)
Primary completion: 31 Jan 2025 (actual)
Study completion: 31 Jan 2025 (actual)
First posted: 27 Mar 2026 (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.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (care provider, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
1 drop	Experimental	Drug: 1 drop of a 0.8% tropicamide + 5% phenylephrine combination1 drop of a 0.8% tropicamide - 5% phenylephrine combination
2 drops	Experimental	Drug: 1 drop of 0.5% tetracaine and 1 drop of a 0.8% tropicamide + 5% phenylephrine combination1 drop of tetracaine and 1 drop of a 0.8% tropicamide - 5% phenylephrine combination
3 drops	Experimental	Drug: 3 drops of a 0.8% tropicamide + 5% phenylephrine combination3 drops of a 0.8% tropicamide - 5% phenylephrine combination
4 drops	Experimental	Drug: 1 drop of 0.5% tetracaine and 3 drops of a 0.8% tropicamide + 5% phenylephrine combination1 drop of tetracaine and 3 drops of a 0.8% tropicamide - 5% phenylephrine combination

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Diabetic patients who were scheduled for diabetic retinopathy screening at OPD eye
Age 18 years or older

Key exclusion criteria (5 listed)

Conditions potentially affecting pupillary reaction (e.g., history of uveitis, previous intraocular surgery, posterior synechiae)
Known allergies to the study medications
Systolic blood pressure > 160 mmHg
Diastolic blood pressure > 100 mmHg
Pulse rate > 100 beats/min

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
1 drop of a 0.8% tropicamide + 5% phenylephrine combination1 drop of a 0.8% tropicamide (muscarinic antagonist) + 5% phenylephrine (α1-adrenergic agonist) combination	Drug	1 drop
1 drop of 0.5% tetracaine and 1 drop of a 0.8% tropicamide + 5% phenylephrine combination1 drop of 0.5% tetracaine (anesthetics) and 1 drop of a 0.8% tropicamide (muscarinic antagonist) + 5% phenylephrine (α1-adrenergic agonist) combination	Drug	2 drops
3 drops of a 0.8% tropicamide + 5% phenylephrine combination3 drops of a 0.8% tropicamide (muscarinic antagonist) + 5% phenylephrine (α1-adrenergic agonist) combination	Drug	3 drops
1 drop of 0.5% tetracaine and 3 drops of a 0.8% tropicamide + 5% phenylephrine combination1 drop of 0.5% tetracaine (anesthetics) and 3 drops of a 0.8% tropicamide (muscarinic antagonist) + 5% phenylephrine (α1-adrenergic agonist) combination	Drug	4 drops

Primary outcome

Pupillary size
Time frame: 30 minutes
Measurement of pupillary size in millimeters (at baseline, then every 10 minutes)

4 secondary outcomes

Systolic blood pressure
Time frame: 30 minutes
Diastolic blood pressure
Time frame: 30 minutes
Pulse rate
Time frame: 30 minutes
Ocular discomfort
Time frame: When all measurements concluded (at minute 30)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
Background: PubMed 22303506Bhatia J, Varghese M, Bhatia A. Effect of 10% phenylephrine eye drops on systemic blood pressure in normotensive & hypertensive patient. Oman Med J. 2009 Jan;24(1):30-2. doi: 10.5001/omj.2009.8.
Background: PubMed 12642324Kenawy NB, Jabir M. Phenylephrine 2.5% and 10% in phacoemulsification under topical anaesthesia: is there an effect on systemic blood pressure? Br J Ophthalmol. 2003 Apr;87(4):505-6. doi: 10.1136/bjo.87.4.505. No abstract available.
Background: PubMed 8090095Chin KW, Law NM, Chin MK. Phenylephrine eye drops in ophthalmic surgery--a clinical study on cardiovascular effects. Med J Malaysia. 1994 Jun;49(2):158-63.
Background: PubMed 7362505Brown MM, Brown GC, Spaeth GL. Lack of side effects from topically administered 10% phenylephrine eyedrops. A controlled study. Arch Ophthalmol. 1980 Mar;98(3):487-9. doi: 10.1001/archopht.1980.01020030483009.
Background: PubMed 655237Leopold IH. The phenylephrine saga--a drug dilemma. Am J Ophthalmol. 1978 Apr;85(4):572-4. doi: 10.1016/s0002-9394(14)75261-4. No abstract available.
Background: PubMed 19478547Motta MM, Coblentz J, Fernandes BF, Burnier MN Jr. Mydriatic and cardiovascular effects of phenylephrine 2.5% versus phenylephrine 10%, both associated with tropicamide 1%. Ophthalmic Res. 2009;42(2):87-9. doi: 10.1159/000220601. Epub 2009 May 27.
Background: PubMed 33727791Shrivastava AK, Nayak S, Anto M. Efficacy of Nepafenac versus Flurbiprofen in Maintaining Intraoperative Mydriasis During Phacoemulsification: A Comparative Study. Clin Ophthalmol. 2021 Mar 9;15:1085-1093. doi: 10.2147/OPTH.S303480. eCollection 2021.
Background: PubMed 2625616Kergoat H, Lovasik JV, Doughty MJ. A pupillographic evaluation of a phenylephrine HCl 5%-tropicamide 0.8% combination mydriatic. J Ocul Pharmacol. 1989 Fall;5(3):199-216. doi: 10.1089/jop.1989.5.199.
Background: PubMed 19700872Trinavarat A, Pituksung A. Effective pupil dilatation with a mixture of 0.75% tropicamide and 2.5% phenylephrine: A randomized controlled trial. Indian J Ophthalmol. 2009 Sep-Oct;57(5):351-4. doi: 10.4103/0301-4738.55070.
Background: PubMed 7258285Pollack SL, Hunt JS, Polse KA. Dose-response effects of tropicamide HCl. Am J Optom Physiol Opt. 1981 May;58(5):361-6. doi: 10.1097/00006324-198105000-00003.
Background: PubMed 7425917Sinclair SH, Pelham V, Giovanoni R, Regan CD. Mydriatic solution for outpatient indirect ophthalmoscopy. Arch Ophthalmol. 1980 Sep;98(9):1572-4. doi: 10.1001/archopht.1980.01020040424004.
Background: PubMed 27321772Bhurayanontachai P, Saengkaew S, Apiromruck P. Efficacy of an eye drop mixture for pupillary dilatation: A randomized comparative study. J Optom. 2017 Apr-Jun;10(2):111-116. doi: 10.1016/j.optom.2016.04.007. Epub 2016 Jun 16.
Individual participant dataSharing planned: Yes. IPD used in the results publication

Related trials for Diabetes (DM)

Not yet recruiting
A Novel Miniature Equine-Assisted Diabetes Education Program for Youth: Evaluating the Diabetes Equine Empowerment Program (DEEP).
Diabetes (Insulin-requiring, Type 1 or Type 2), Pediatric Diabetes
Recruiting
Continuous Monitoring of Plantar Temperature Variations Using Connected Insoles and a Mobile Application for Diabetic Foot.
Diabetic Foot Disease, Diabetic Foot Infection
Enrolling by invitationObservational study
Personalizing A1c Using Hematologic Indices and CGM for Accurate Diabetes Diagnosis
Type 2 Diabetes
Active, not recruitingObservational study
Evaluation of MTHFR and DNMT3B Gene Polymorphisms Along With Periodontal Clinical Parameters in Healthy Individuals and Individuals With Type 2 Diabetes and Periodontitis
Periodontitis, Type 2 Diabetes Mellitus (DM)
RecruitingObservational study
Dietitian-Nutritionist vs. Day Hospital in the Metabolic Control of Patients With Type 2 Diabetes
Diabetes (DM)

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.

Nattawat Asawaworarit, M.D. principal investigator

Burapha University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 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: finished, as of the sponsor's last update on 27 Mar 2026. 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 Thailand. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Pupillary size (time frame: 30 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 NCT07495670, which also lists 23 linked publications.

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 27 Mar 2026.