Type 2 Diabetes MellitusPhase 3NCT04932213
Effect of Tropicamide 0.5% vs Tropicamide 1% on Intraocular Pressure of Diabetic Patients
A Phase 3 study testing Tropicamide Ophthalmic in people with Type 2 Diabetes Mellitus and Type 1 Diabetes Mellitus, run by Semnan University of Medical Sciences at 1 site in Iran.
Trial summary
The aim of this study is to compare the effect of tropicamide 0.5% and tropicamide 1% on intraocular pressure and anterior chamber parameters in patients with Diabetes Mellitus. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus, Type 1 Diabetes Mellitus
- What is being tested?
- Tropicamide Ophthalmic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteIran
- Study dates
- 7 Jul 2021to 7 Nov 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Diabetes Mellitus type 1 and 2
Who cannot join
- Proliferative diabetic retinopathy
- History of cataract surgery
- severe nuclear and cortical cataract
- Glaucoma
- Intraocular pressure (IOP) greater than 21 mmHg
- Familial history of glaucoma
Show all 17Show fewer
- Narrow angle (Van Herick 1, 2)
- Cup to disc ratio greater than 0.5
- Pregnancy
- Pterygium
- Corneal ectasia
- History of keratorefractive surgery
- Corneal dystrophy
- Iris disorders
- Anisocoria
- Iris neovascularization
- Use of miotics or mydriatics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effect of Tropicamide 0.5% and Tropicamide 1% on Intraocular Pressure, Pupil Size, Keratometry and Anterior Chamber Parameters in Patients With Type 1 and Type 2 Diabetes Mellitus
The aim of this study is to compare the effect of tropicamide 0.5% and tropicamide 1% on intraocular pressure and anterior chamber parameters in patients with Diabetes Mellitus.
Read the detailed description
Patients with diabetes type 1 and type 2 older than 21 years of age, in the specialized clinic of Kowsar Hospital (Semnan University of Medical Sciences) are examined. Eligible individuals enter the study and are randomly assigned to group 1 or group 2. In each group, visual acuity measurement, slit lamp biomicroscopy and fundus examination are performed. Intraocular pressure is measured with Goldmann applanation tonometer. pupil size, refraction and keratometry are measured with two different autorefractokeratometers. keratometry, pupil size and other anterior chamber parameters are also evaluated by Oculus Pentacam imaging. Then, the patients receive tropicamide 0.5% drops in group 1 and tropicamide 1% drops in group 2. 30 minutes later, all previous measurements are repeated. Patients and the ophthalmologist and the data analyzer are unaware of the drug type.
- Conditions
- Type 2 Diabetes Mellitus, Type 1 Diabetes Mellitus
- Being tested
- Tropicamide Ophthalmic
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tropicamide OphthalmicDrug
Also called Mydrax (Sina Darou)
Tropicamide eye drops are used for dilating pupils (mydriasis) to do comprehensive fundus examination.
| Study group | Role | What they receive |
|---|---|---|
| Tropicamide 0.5% | Active comparator | This group receives tropicamide 0.5% (one drop every 5 minutes for 2 times) drops. Receives: Drug: Tropicamide Ophthalmic |
| Tropicamide 1% | Active comparator | This group receives tropicamide 1% (one drop every 5 minutes for 2 times) drops. Receives: Drug: Tropicamide Ophthalmic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Intraocular pressure (IOP)
The intraocular pressure is measured by Goldmann applanation tonometry
Measured: Before intervention, 30 minutes after intervention
Change from baseline in pupillary diameter
The diameter of the participants' pupil is measured by Scheimpflug camera (Oculus Pentacam); Autorefractokeratometer (TOMEY RC-5000 and Topcon KR-1)
Measured: Before intervention, 30 minutes after intervention
Secondary outcomes (5)
Change from baseline in Keratometry
The keratometry is obtained by Scheimpflug camera (Oculus Pentacam); Autorefractokeratometer (TOMEY RC-5000 and Topcon KR-1)
Measured: Before intervention, 30 minutes after intervention
Change from baseline in anterior chamber depth (ACD)
The ACD is measured by Scheimpflug camera (Oculus Pentacam)
Measured: Before intervention, 30 minutes after intervention
Change from baseline in anterior chamber volume (ACV)
The ACV is measured by Scheimpflug camera (Oculus Pentacam)
Measured: Before intervention, 30 minutes after intervention
Change from baseline in anterior chamber angle (ACA)
The ACA is measured by Scheimpflug camera (Oculus Pentacam)
Measured: Before intervention, 30 minutes after intervention
Change from baseline in central corneal thickness (CCT)
The CCT is measured by Scheimpflug camera (Oculus Pentacam)
Measured: Before intervention, 30 minutes after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start7 Jul 2021
- Primary completion7 Nov 2021
- Study completion7 Nov 2021
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 Type 2 Diabetes MellitusStudies 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
- Intervention group 1: This group receives tropicamide 0.5% drops; Intervention group 2: This group receives tropicamide 1% drops.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semnan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Navid Elmi Sadr, Semnan University of Medical Sciences
- Investigators
- Navid Elmi Sadr, MD, Principal investigator, Semnan University of Medical Sciences, Semnan, IranNavid Elmi Sadr, MD, Study director, Semnan University of Medical Sciences, Semnan, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04932213
- Sponsor's protocol ID
- IR.SEMUMS.REC.1400.018
- Other IDs
- IRCT
- Status last verified
- Nov 2021
- First submitted
- 7 Jun 2021
- Last updated
- 19 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data can be shared without disclosing the identities of the participants.
Publications
Elmi Sadr N, Ghiasian L, Hadi Y, Hariri R. The effect of cycloplegia on corneal power and diameter measured by an auto-kerato-refractometer in presbyopic patients with type 2 diabetes mellitus: a post-hoc analysis of a randomized clinical trial. BMC Ophthalmol. 2026 Sep 18;26(1):588. doi: 10.1186/s12886-026-05351-1.
PubMed 42768324
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Tropicamide 0.5% and Tropicamide 1% on Intraocular Pressure, Pupil Size, Keratometry and Anterior Chamber Parameters in Patients With Type 1 and Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04932213
- Acronym / sponsor ID
- IR.SEMUMS.REC.1400.018
- Conditions
- Type 2 Diabetes Mellitus, Type 1 Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Semnan University of Medical SciencesUniversity, hospital or other
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 7 Nov 2021 (actual)
- Study completion
- 7 Nov 2021 (actual)
- First posted
- 21 Jun 2021 (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 aim of this study is to compare the effect of tropicamide 0.5% and tropicamide 1% on intraocular pressure and anterior chamber parameters in patients with Diabetes Mellitus.
Detailed description
Patients with diabetes type 1 and type 2 older than 21 years of age, in the specialized clinic of Kowsar Hospital (Semnan University of Medical Sciences) are examined. Eligible individuals enter the study and are randomly assigned to group 1 or group 2. In each group, visual acuity measurement, slit lamp biomicroscopy and fundus examination are performed. Intraocular pressure is measured with Goldmann applanation tonometer. pupil size, refraction and keratometry are measured with two different autorefractokeratometers. keratometry, pupil size and other anterior chamber parameters are also evaluated by Oculus Pentacam imaging. Then, the patients receive tropicamide 0.5% drops in group 1 and tropicamide 1% drops in group 2. 30 minutes later, all previous measurements are repeated. Patients and the ophthalmologist and the data analyzer are unaware of the drug type.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention group 1: This group receives tropicamide 0.5% drops; Intervention group 2: This group receives tropicamide 1% drops.
| Arm | Type | Receives |
|---|---|---|
| Tropicamide 0.5% | Active comparator | Drug: Tropicamide OphthalmicThis group receives tropicamide 0.5% (one drop every 5 minutes for 2 times) drops. |
| Tropicamide 1% | Active comparator | Drug: Tropicamide OphthalmicThis group receives tropicamide 1% (one drop every 5 minutes for 2 times) drops. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with Diabetes Mellitus type 1 and 2
Key exclusion criteria (17 listed)
- Proliferative diabetic retinopathy
- History of cataract surgery
- severe nuclear and cortical cataract
- Glaucoma
- Intraocular pressure (IOP) greater than 21 mmHg
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 |
|---|---|---|
| Tropicamide OphthalmicAlso: Mydrax (Sina Darou)Tropicamide eye drops are used for dilating pupils (mydriasis) to do comprehensive fundus examination. | Drug | Tropicamide 0.5%, Tropicamide 1% |
Primary outcome
Change from baseline in Intraocular pressure (IOP)
Time frame: Before intervention, 30 minutes after intervention
The intraocular pressure is measured by Goldmann applanation tonometry
Change from baseline in pupillary diameter
Time frame: Before intervention, 30 minutes after intervention
The diameter of the participants' pupil is measured by Scheimpflug camera (Oculus Pentacam); Autorefractokeratometer (TOMEY RC-5000 and Topcon KR-1)
5 secondary outcomes
Change from baseline in Keratometry
Time frame: Before intervention, 30 minutes after intervention
Change from baseline in anterior chamber depth (ACD)
Time frame: Before intervention, 30 minutes after intervention
Change from baseline in anterior chamber volume (ACV)
Time frame: Before intervention, 30 minutes after intervention
Change from baseline in anterior chamber angle (ACA)
Time frame: Before intervention, 30 minutes after intervention
Change from baseline in central corneal thickness (CCT)
Time frame: Before intervention, 30 minutes after intervention
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 19 Nov 2021.
- Derived from this study: PubMed 42768324Elmi Sadr N, Ghiasian L, Hadi Y, Hariri R. The effect of cycloplegia on corneal power and diameter measured by an auto-kerato-refractometer in presbyopic patients with type 2 diabetes mellitus: a post-hoc analysis of a randomized clinical trial. BMC Ophthalmol. 2026 Sep 18;26(1):588. doi: 10.1186/s12886-026-05351-1.
- Individual participant dataSharing planned: Yes. Data can be shared without disclosing the identities of the participants.
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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.
Navid Elmi Sadr, MD principal investigator
Semnan University of Medical Sciences, Semnan, Iran
Navid Elmi Sadr, MD study director
Semnan University of Medical Sciences, Semnan, 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 Tropicamide Ophthalmic in people with Type 2 Diabetes Mellitus and Type 1 Diabetes Mellitus, run by Semnan 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 1 inclusion and 17 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 19 Nov 2021. 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?
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?
Change from baseline in Intraocular pressure (IOP) (time frame: Before intervention, 30 minutes after intervention). The study lists 2 primary outcomes in all. 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 NCT04932213, 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 19 Nov 2021.