Dry EyeNCT07675460
Systemic Isotretinoin Therapy and Eye
A study testing Isotretinoin (13-cis-retinoic acid) in people with Dry Eye and Choroidal Thickness, run by Demet Mutlu at 1 site in Turkey (Türkiye).
Trial summary
The dermatologist created a treatment plan for participants diagnosed with acne using medications containing vitamin A. While this medication has many benefits for the skin, it also has various side effects affecting many other systems. One of the most important of these side effects is related to the eyes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye, Choroidal Thickness, Retinal Vascularisation
- What is being tested?
- Isotretinoin (13-cis-retinoic acid)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2024to 1 Nov 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
- Being over 18 years of age
- Having been diagnosed with cystic acne
Who cannot join
- History of glaucoma or ocular hypertension
- Prior ocular surgical interventions
- Any diagnosed ophthalmic condition,
- Refractive errors exceeding 1.00 diopter axial length outside the 22 mm to 24 mm range
- Oongoing dry eye therapy
- Any systemic/local disorder known to impact retinal or choroidal vascularite or thickness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Systemic Isotretinoin Therapy on Choroidal Thickness and Retinal Vascular Parameters in Nodulocystic Acne Patients:A Prospevtive Study
The dermatologist created a treatment plan for participants diagnosed with acne using medications containing vitamin A. While this medication has many benefits for the skin, it also has various side effects affecting many other systems. One of the most important of these side effects is related to the eyes. Therefore, the dermatologist will refer participants to an eye clinic for eye exams before and at regular intervals after starting this medication. During these exams, the investigators will perform eye measurements, a dry eye test, and an eye CT scan (OCTA). This study will compare patients who are scheduled to start treatment with vitamin A-containing pills for acne treatment with patients who have started treatment and completed their sixth month. This will allow for the early detection of potential side effects associated with this medication.
- Conditions
- Dry Eye, Choroidal Thickness, Retinal Vascularisation, Acne Cystic, Isotretinoin
- Being tested
- Isotretinoin (13-cis-retinoic acid)
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isotretinoin (13-cis-retinoic acid)Drug
No different dosage was used compared to other studies. In addition, more ocular layers were examined using imaging techniques to allow for early diagnosis of possible drug-related side effects.
| Study group | Role | What they receive |
|---|---|---|
| Received systemic isotretinoin treatment for six months | Other | Not described Receives: Drug: Isotretinoin (13-cis-retinoic acid) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0
In the participant group receiving treatment for through study completion, any statistically significant change in DVD, SVD, CVD values or Shirmer test scores in OCTA data will be considered a treatment-related side effect.
Measured: From enrollment to the end of treatment at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start1 Apr 2024
- Primary completion1 Jul 2025
- Study completion1 Nov 2025
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 Dry EyeStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Demet Mutlu
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Demet Mutlu, Kayseri City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07675460
- Sponsor's protocol ID
- 2024/1
- Status last verified
- Jun 2026
- First submitted
- 12 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the personal data protection laws in our country, sharing this information is not considered.
Publications
Mutlu D, Uzunovali B. Effects of systemic isotretinoin therapy on tear function and choroidal thickness in nodulocystic acne patients: a prospective comparative study. BMC Ophthalmol. 2026 Oct 17;26(1):660. doi: 10.1186/s12886-026-05428-x.
PubMed 42897500
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Systemic Isotretinoin Therapy on Choroidal Thickness and Retinal Vascular Parameters in Nodulocystic Acne Patients:A Prospevtive Study
- ClinicalTrials.gov ID
- NCT07675460
- Acronym / sponsor ID
- 2024/1
- Conditions
- Dry Eye, Choroidal Thickness, Retinal Vascularisation, Acne Cystic, Isotretinoin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Demet MutluOther government
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 30 Jun 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.
The dermatologist created a treatment plan for participants diagnosed with acne using medications containing vitamin A. While this medication has many benefits for the skin, it also has various side effects affecting many other systems. One of the most important of these side effects is related to the eyes. Therefore, the dermatologist will refer participants to an eye clinic for eye exams before and at regular intervals after starting this medication. During these exams, the investigators will perform eye measurements, a dry eye test, and an eye CT scan (OCTA). This study will compare patients who are scheduled to start treatment with vitamin A-containing pills for acne treatment with patients who have started treatment and completed their sixth month. This will allow for the early detection of potential side effects associated with this medication.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Received systemic isotretinoin treatment for six months | Other | Drug: Isotretinoin (13-cis-retinoic acid) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Being over 18 years of age
- Having been diagnosed with cystic acne
Key exclusion criteria (6 listed)
- History of glaucoma or ocular hypertension
- Prior ocular surgical interventions
- Any diagnosed ophthalmic condition,
- Refractive errors exceeding 1.00 diopter axial length outside the 22 mm to 24 mm range
- Oongoing dry eye therapy
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 |
|---|---|---|
| Isotretinoin (13-cis-retinoic acid)No different dosage was used compared to other studies. In addition, more ocular layers were examined using imaging techniques to allow for early diagnosis of possible drug-related side effects. | Drug | Received systemic isotretinoin treatment for six months |
Primary outcome
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Time frame: From enrollment to the end of treatment at 24 weeks
In the participant group receiving treatment for through study completion, any statistically significant change in DVD, SVD, CVD values or Shirmer test scores in OCTA data will be considered a treatment-related side effect.
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 30 Jun 2026.
- Derived from this study: PubMed 42897500Mutlu D, Uzunovali B. Effects of systemic isotretinoin therapy on tear function and choroidal thickness in nodulocystic acne patients: a prospective comparative study. BMC Ophthalmol. 2026 Oct 17;26(1):660. doi: 10.1186/s12886-026-05428-x.
- Individual participant dataSharing planned: No. Due to the personal data protection laws in our country, sharing this information is not considered.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isotretinoin (13-cis-retinoic acid) in people with Dry Eye and Choroidal Thickness, run by Demet Mutlu at 1 site in Turkey (Türkiye).
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 6 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 30 Jun 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 Turkey (Türkiye). 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?
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0 (time frame: From enrollment to the end of treatment at 24 weeks). 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 NCT07675460, 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 30 Jun 2026.