Conjunctivitis, AllergicNCT04299399
Corneal Biomechanical Changes of Allergic Conjunctivitis
An observational study of Conjunctivitis, Allergic and Keratoconus, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial summary
By measuring and comparing the corneal biomechanical parameters of normal people, patients with allergic conjunctivitis, keratoconus, whether allergic conjunctivitis causes changes in corneal biomechanics can be explored, and sensitive mechanical indicators of allergic conjunctivitis can be identified. Read more about this study
- Who is it for?
- Ages 7 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Conjunctivitis, Allergic, Keratoconus
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2019to 30 Jun 2021
- Phase
- Observational
- 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 7 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The patients of Zhongshan ophthalmic center and healthy volunteers recruited.
Who may be able to join
- No abnormalities are found by slit lamp and Pentacam.
- Diopters: diopter of spherical: -6.0D~+3.0D, diopter of cylinder: -2.0D~+2.0D, spherical equivalent: -6.0D~+3.0D
- Best corrected visual acuity ≥ 1.0
- Symptoms: Itching, foreign body sensation, increased discharge in conjunctival sac. And children may mainly show an increase in blinking frequency.
- Signs: conjunctival hyperemia, swelling, tarsal papillae.
- Medical history: seasonal onset
Show all 16Show fewer
- Diopters: diopter of spherical: -6.0D~+3.0D, diopter of cylinder: -2.0D~+2.0D, spherical equivalent: -6.0D~+3.0D
- Best corrected visual acuity ≥ 0.8
- Symptoms: Itching, foreign body sensation, increased discharge in conjunctival sac. And children may mainly show an increase in blinking frequency.
- Signs: giant papillae on the upper tarsal conjunctiva and gelatinous infiltration of the limbus.
- Diopters: diopter of spherical: -6.0D~+3.0D, diopter of cylinder: -2.0D~+2.0D, spherical equivalent: -6.0D~+3.0D
- Best corrected visual acuity ≥ 0.8
- With a history of myopia and astigmatism
- Best corrected visual acuity <1.0
- At least 1 positive sign of the following is found by slit lamp examination: thinning of the corneal stroma, a cone-shaped ectatic protrusion of the cornea, Fleischer ring and Vogt striae.
- Typical signs of corneal topography: central corneal power value of the anterior surface >47D, central inferior/superior dioptric asymmetry >3D (within 3mm), central dioptric asymmetry between two eyes >1D.
Who cannot join
- Patients diagnosed with other eye diseases other than refractive error.
- With a history of eye surgery or trauma.
- With systemic diseases such as immune diseases and connective tissue diseases.
- With a family history of keratoconus and glaucoma.
- Wear soft contact lens within 2 weeks or rigid contact lens within 1 month.
- SAC group
Show all 16Show fewer
- Corneal scar.
- Other active inflammatory diseases of the eye.
- With a history of eye surgery or trauma.
- With systemic diseases such as immune diseases and connective tissue diseases.
- Wear soft contact lens within 2 weeks or rigid contact lens within 1 month.
- Unable to fixate and cooperate.
- VKC group
- The same as SAC group.
- Keratoconus group
- The same as SAC group.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Ophthalmic Center, Sun Yat-Sen University
Guangzhou, 510060
Qian Wang, MD, 86-018843014719, 419059130@qq.com
Jin Yuan, PHD
About this study
Official title: Corneal Biomechanical Changes and Related Risk Prediction in Allergic Conjunctivitis
By measuring and comparing the corneal biomechanical parameters of normal people, patients with allergic conjunctivitis, keratoconus, whether allergic conjunctivitis causes changes in corneal biomechanics can be explored, and sensitive mechanical indicators of allergic conjunctivitis can be identified. Furthermore, through rubbing frequency, ocular allergic symptom scores and physical sign scores observation, corneal morphological parameters, corneal epithelial thickness, tear inflammatory cytokines levels, and conjunctival microvascular parameters measurements, related factors affecting corneal biomechanics in patients with allergic conjunctivitis can be identified. Otherwise, by comparing corneal biomechanical changes in vernal keratoconjunctivitis before and after drug treatment, biomechanical change tendency during treatment can be clarified.
Read the detailed description
The current study involves 3 parts. The first part aims to explore whether allergic conjunctivitis causes changes in corneal biomechanics and to identify sensitive mechanical indicators of allergic conjunctivitis. This part is a cross-sectional study. Four groups are included: normal group, vernal keratoconjunctivitis (VKC) group, seasonal allergic conjunctivitis (SAC) group and keratoconus (KC) group, with 25 eyes in each group (in normal group one eye is randomly selected , and in VKC group, SAC group and KC group the more severe one is selected). Patients in all groups meet inclusion criteria and voluntarily join this study with informed consents. Medical history is collected, including basic information, allergic history and course of disease. Corneal biomechanics is measured by Corvis ST. The difference of corneal biomechanics among groups is analyzed to determine corneal biomechanical changes of AC and to find sensitive mechanical indicators of AC.
The second part aims to identify related factors affecting corneal biomechanics in patients with allergic conjunctivitis. This part is also a cross-sectional study. Four groups are included: normal group, VKC group, SAC group and KC group, with 25 eyes in each group. Medical history is collected, including basic information, allergic history and course of disease. Eye rubbing frequency, ocular allergic symptom scores and physical sign scores are measured and recorded in VKC group and SAC group. Corneal biomechanics measured by Corvis ST, corneal morphological parameters measured by Pentacam, corneal epithelial thickness measured by Optovue OCT, tear cytokine levels measured by Milliplex kit and conjunctival microvascular parameters measured by functional slit lamp are performed in all patients. Correlation analysis of corneal biomechanical parameters and other measurement indicators in VKC group and SAC group is performed to determine the relevant influencing factors of corneal biomechanics in AC.
The third part aims to determine corneal biomechanical change tendency during treatment in VKC. This part is a prospective case-control study. 25 patients with 25 eyes (the more severe eye is selected) are included. Medical history is collected, including basic information, allergic history and course of disease. Eye rubbing frequency, ocular allergic symptom scores and physical sign scores are measured and recorded in VKC group and SAC group. Corneal biomechanics measured by Corvis ST, corneal morphological parameters measured by Pentacam, corneal epithelial thickness measured by Optovue OCT, tear cytokine levels measured by Milliplex kit and conjunctival microvascular parameters measured by functional slit lamp are performed in all patients before drug treatment. And all the patients adopt a unified medication regimen. The same ophthalmological examinations are performed again after 3 month medication. Based on the analysis of the difference between the two measurements before and after the drug treatment, corneal biomechanical change tendency during treatment in VKC is clarified and the potential mechanical parameter needed to be monitored during follow-up is identified. The specific therapeutic regimen is as follows: 0.1% tacrolimus eye drops four times daily; 0.1% flumirone eye drops twice daily; azelastine hydrochloride eye drops four times daily; hyaluronic acid sodium eye drops four times daily. After 1M, 0.1% flumilone eye drops is replaced with 0.02% flumirone eye drops twice daily, and the rest of the medication remaines unchanged.
- Conditions
- Conjunctivitis, Allergic, Keratoconus
- Keywords
- Allergic conjunctivitis, Corneal biomechanics, Keratoconus
- Medical subject headings
- Conjunctivitis, Allergic, Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| nomal | Corneal biomechanics, corneal topographic parameters, corneal epithelial thickness, tear inflammatory cytokines levels and conjunctival microvascular parameters will be measured, and comparative analysis of biomechanics with other groups will be performed. | |
| seasonal allergic conjunctivitis(SAC) | Eye rubbing frequency, ocular allergy symptom scores, physical sign scores, corneal biomechanics, corneal topographic parameters, corneal epithelial thickness, tear inflammatory cytokines levels and conjunctival microvascular parameters will be measured, and comparative analysis of corneal biomechanics with other groups and correlation analysis of corneal biomechanical parameters and other measurement indicators will be performed. | |
| vernal keratoconjunctivitis (VKC) | At first visit, eye rubbing frequency, ocular allergy symptom scores, physical sign scores, corneal biomechanics, corneal topographic parameters, corneal epithelial thickness, tear inflammatory cytokines levels and conjunctival microvascular parameters will be measured. All patients will adopt a unified medication regimen:0.1% tacrolimus eye drops four times daily; 0.1% flumirone eye drops twice daily; azelastine hydrochloride eye drops four times daily; hyaluronic acid sodium eye drops four times daily. After 1M, 0.1% flumilone eye drops will be replaced with 0.02% flumirone eye drops twice daily, and rest of the medication will remain unchanged. The same ophthalmological examinations will be performed again after 3 month medication. | |
| keratoconus | Corneal biomechanics, corneal topographic parameters, corneal epithelial thickness, tear inflammatory cytokines levels and conjunctival microvascular parameters will be measured, and comparative analysis of these parameters with other groups will be performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal biomechanics
The corneal biomechanics parameters are measure by Corvis ST, including A1 Time, A1 Velocity, A2 Time, A2 Velocity, HC Time, PD, DA, SP-A1, CBI, TBI and so on.
Measured: Baseline in all groups and after 3m medication in VKC group
Secondary outcomes (7)
Eye rubbing frequency
According to the frequency of eye rubbing, the scores range from 0 to 5 points, 0 point represents no eye rubbing, 1 point means very few eye rubbing, and 5 points represents eye rubbing all the time.
Measured: Baseline in SAC and VKC group, and after 3m medication in VKC group
Ocular allergic symptom scores
Ocular allergic symptoms are evaluated from six aspects: itching, redness, tearing, foreign body sensation, photophobia, and discharges. The scores range from 0 to 3 according to the severity of each symptom. 0 point means no symptoms, 3 points represents serious symptoms. And the total ocular allergic symptom scores range from 0 to 18.
Measured: Baseline in SAC and VKC group, and after 3m medication in VKC group
Ocular sign scores
Ocular sign scores are evaluated from three major aspects: conjunctiva, limbus and cornea. Conjunctival signs include hyperemia, swelling and tarsal papillae. Limbal signs include swelling and Horner-Trantas dots. Corneal sign is evaluated according to corneal epithelial staining. According to the severity of each sign, the sign scores range from 0 to 3 respectively, with 0 point indicating no corresponding signs and 3 points representing serious signs. And the total ocular sign scores range from 0 to 18.
Measured: Baseline in SAC and VKC group, and after 3m medication in VKC group
Morphological parameters of corneal topography
The morphological parameters are measure by Pentacam, including K1, K2, Km of the front and back surface, astigmatism, ISV, IVA, IHD, KI, CKI, IHA, BAD-D and corneal ocular densitometry.
Measured: Baseline in all groups and after 3m medication in VKC group
Corneal epithelial thickness
The corneal epithelial thickness parameters are measured by RTvue OCT, including corneal thickness map and corneal epithelial thickness map within 9 mm, which are divided into four concentric circles with the diameters of 2mm, 5mm, 7mm and 9mm respectively. And the area between adjacent concentric circles are divided into 8 different areas, including superior, superior-temporal, temporal, temporal-inferior, inferior, inferior-nasal, nasal, and superior-nasal area, with a total of 25 areas.
Measured: Baseline in all groups and after 3m medication in VKC group
Conjunctival microvascular parameters
Conjunctival microvascular parameters are measured by functional slit-lamp biomicroscope，including Va, Vs, Q, Mean Diameter, Dbox and D0.
Measured: Baseline in all groups and after 3m medication in VKC group
Tear inflammatory cytokines levels
Kinds of tear inflammatory cytokines levels are measured, including ITAC, GM-CSF, Fractalkine, IFNy, IL-10, MIP-3a, IL-12(p70), IL-13, IL-17A, IL-1b, IL-2, IL-21, IL-4, IL-23, IL-5, IL-6, IL-7, IL-8, MIP-1a, MIP-1b and TFNa.
Measured: Baseline in all groups and after 3m medication in VKC group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start10 Nov 2019
- Primary completion31 May 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Conjunctivitis, AllergicStudies of the same condition, open and under way.
- More trials run by Zhongshan Ophthalmic Center, Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Yuan, Zhongshan Ophthalmic Center, Sun Yat-sen University
- Investigators
- Jin Yuan, PhD, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04299399
- Sponsor's protocol ID
- 2019045
- Status last verified
- Mar 2020
- First submitted
- 3 Mar 2020
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang Q, Yu F, Feng Z, Li W, Li N, Du X, Zhao X, Li S, Yuan J. Changes in Anterior and Posterior Corneal Elevation in Patients With Allergic Conjunctivitis. Front Med (Lausanne). 2021 Nov 24;8:788302. doi: 10.3389/fmed.2021.788302. eCollection 2021.
PubMed 34901095Wang Q, Deng Y, Li S, Du X, Zhao X, Zhang T, Yuan J. Corneal biomechanical changes in allergic conjunctivitis. Eye Vis (Lond). 2021 May 3;8(1):17. doi: 10.1186/s40662-021-00241-7.
PubMed 33934706
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corneal Biomechanical Changes and Related Risk Prediction in Allergic Conjunctivitis
- ClinicalTrials.gov ID
- NCT04299399
- Acronym / sponsor ID
- 2019045
- Conditions
- Conjunctivitis, Allergic, Keratoconus
- Keywords
- Allergic conjunctivitis, Corneal biomechanics, Keratoconus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 10 Nov 2019 (actual)
- Primary completion
- 31 May 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 6 Mar 2020 (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.
By measuring and comparing the corneal biomechanical parameters of normal people, patients with allergic conjunctivitis, keratoconus, whether allergic conjunctivitis causes changes in corneal biomechanics can be explored, and sensitive mechanical indicators of allergic conjunctivitis can be identified. Furthermore, through rubbing frequency, ocular allergic symptom scores and physical sign scores observation, corneal morphological parameters, corneal epithelial thickness, tear inflammatory cytokines levels, and conjunctival microvascular parameters measurements, related factors affecting corneal biomechanics in patients with allergic conjunctivitis can be identified. Otherwise, by comparing corneal biomechanical changes in vernal keratoconjunctivitis before and after drug treatment, biomechanical change tendency during treatment can be clarified.
Detailed description
The current study involves 3 parts. The first part aims to explore whether allergic conjunctivitis causes changes in corneal biomechanics and to identify sensitive mechanical indicators of allergic conjunctivitis. This part is a cross-sectional study. Four groups are included: normal group, vernal keratoconjunctivitis (VKC) group, seasonal allergic conjunctivitis (SAC) group and keratoconus (KC) group, with 25 eyes in each group (in normal group one eye is randomly selected , and in VKC group, SAC group and KC group the more severe one is selected). Patients in all groups meet inclusion criteria and voluntarily join this study with informed consents. Medical history is collected, including basic information, allergic history and course of disease. Corneal biomechanics is measured by Corvis ST. The difference of corneal biomechanics among groups is analyzed to determine corneal biomechanical changes of AC and to find sensitive mechanical indicators of AC.
The second part aims to identify related factors affecting corneal biomechanics in patients with allergic conjunctivitis. This part is also a cross-sectional study. Four groups are included: normal group, VKC group, SAC group and KC group, with 25 eyes in each group. Medical history is collected, including basic information, allergic history and course of disease. Eye rubbing frequency, ocular allergic symptom scores and physical sign scores are measured and recorded in VKC group and SAC group. Corneal biomechanics measured by Corvis ST, corneal morphological parameters measured by Pentacam, corneal epithelial thickness measured by Optovue OCT, tear cytokine levels measured by Milliplex kit and conjunctival microvascular parameters measured by functional slit lamp are performed in all patients. Correlation analysis of corneal biomechanical parameters and other measurement indicators in VKC group and SAC group is performed to determine the relevant influencing factors of corneal biomechanics in AC.
The third part aims to determine corneal biomechanical change tendency during treatment in VKC. This part is a prospective case-control study. 25 patients with 25 eyes (the more severe eye is selected) are included. Medical history is collected, including basic information, allergic history and course of disease. Eye rubbing frequency, ocular allergic symptom scores and physical sign scores are measured and recorded in VKC group and SAC group. Corneal biomechanics measured by Corvis ST, corneal morphological parameters measured by Pentacam, corneal epithelial thickness measured by Optovue OCT, tear cytokine levels measured by Milliplex kit and conjunctival microvascular parameters measured by functional slit lamp are performed in all patients before drug treatment. And all the patients adopt a unified medication regimen. The same ophthalmological examinations are performed again after 3 month medication. Based on the analysis of the difference between the two measurements before and after the drug treatment, corneal biomechanical change tendency during treatment in VKC is clarified and the potential mechanical parameter needed to be monitored during follow-up is identified. The specific therapeutic regimen is as follows: 0.1% tacrolimus eye drops four times daily; 0.1% flumirone eye drops twice daily; azelastine hydrochloride eye drops four times daily; hyaluronic acid sodium eye drops four times daily. After 1M, 0.1% flumilone eye drops is replaced with 0.02% flumirone eye drops twice daily, and the rest of the medication remaines unchanged.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| nomal | – | –Corneal biomechanics, corneal topographic parameters, corneal epithelial thickness, tear inflammatory cytokines levels and conjunctival microvascular parameters will be measured, and comparative analysis of biomechanics with other groups will be performed. |
| seasonal allergic conjunctivitis(SAC) | – | –Eye rubbing frequency, ocular allergy symptom scores, physical sign scores, corneal biomechanics, corneal topographic parameters, corneal epithelial thickness, tear inflammatory cytokines levels and conjunctival microvascular parameters will be measured, and comparative analysis of corneal biomechanics with other groups and correlation analysis of corneal biomechanical parameters and other measurement indicators will be performed. |
| vernal keratoconjunctivitis (VKC) | – | –At first visit, eye rubbing frequency, ocular allergy symptom scores, physical sign scores, corneal biomechanics, corneal topographic parameters, corneal epithelial thickness, tear inflammatory cytokines levels and conjunctival microvascular parameters will be measured. All patients will adopt a unified medication regimen:0.1% tacrolimus eye drops four times daily; 0.1% flumirone eye drops twice daily; azelastine hydrochloride eye drops four times daily; hyaluronic acid sodium eye drops four times daily. After 1M, 0.1% flumilone eye drops will be replaced with 0.02% flumirone eye drops twice daily, and rest of the medication will remain unchanged. The same ophthalmological examinations will be performed again after 3 month medication. |
| keratoconus | – | –Corneal biomechanics, corneal topographic parameters, corneal epithelial thickness, tear inflammatory cytokines levels and conjunctival microvascular parameters will be measured, and comparative analysis of these parameters with other groups will be performed. |
Who may qualify
- Ages
- 7 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The patients of Zhongshan ophthalmic center and healthy volunteers recruited.
Key inclusion criteria (16 listed)
- No abnormalities are found by slit lamp and Pentacam.
- Diopters: diopter of spherical: -6.0D~+3.0D, diopter of cylinder: -2.0D~+2.0D, spherical equivalent: -6.0D~+3.0D
- Best corrected visual acuity ≥ 1.0
- Symptoms: Itching, foreign body sensation, increased discharge in conjunctival sac. And children may mainly show an increase in blinking frequency.
- Signs: conjunctival hyperemia, swelling, tarsal papillae.
Key exclusion criteria (16 listed)
- Patients diagnosed with other eye diseases other than refractive error.
- With a history of eye surgery or trauma.
- With systemic diseases such as immune diseases and connective tissue diseases.
- With a family history of keratoconus and glaucoma.
- Wear soft contact lens within 2 weeks or rigid contact lens within 1 month.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Corneal biomechanics
Time frame: Baseline in all groups and after 3m medication in VKC group
The corneal biomechanics parameters are measure by Corvis ST, including A1 Time, A1 Velocity, A2 Time, A2 Velocity, HC Time, PD, DA, SP-A1, CBI, TBI and so on.
7 secondary outcomes
Eye rubbing frequency
Time frame: Baseline in SAC and VKC group, and after 3m medication in VKC group
Ocular allergic symptom scores
Time frame: Baseline in SAC and VKC group, and after 3m medication in VKC group
Ocular sign scores
Time frame: Baseline in SAC and VKC group, and after 3m medication in VKC group
Morphological parameters of corneal topography
Time frame: Baseline in all groups and after 3m medication in VKC group
Corneal epithelial thickness
Time frame: Baseline in all groups and after 3m medication in VKC group
Conjunctival microvascular parameters
Time frame: Baseline in all groups and after 3m medication in VKC group
Tear inflammatory cytokines levels
Time frame: Baseline in all groups and after 3m medication in VKC group
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
- Derived from this study: PubMed 34901095Wang Q, Yu F, Feng Z, Li W, Li N, Du X, Zhao X, Li S, Yuan J. Changes in Anterior and Posterior Corneal Elevation in Patients With Allergic Conjunctivitis. Front Med (Lausanne). 2021 Nov 24;8:788302. doi: 10.3389/fmed.2021.788302. eCollection 2021.
- Derived from this study: PubMed 33934706Wang Q, Deng Y, Li S, Du X, Zhao X, Zhang T, Yuan J. Corneal biomechanical changes in allergic conjunctivitis. Eye Vis (Lond). 2021 May 3;8(1):17. doi: 10.1186/s40662-021-00241-7.
- 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. This study is not recruiting at the moment.
Jin Yuan, PhD principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Conjunctivitis, Allergic and Keratoconus, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
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 16 inclusion and 16 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 6 Mar 2020. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qian wang, MD (86-018843014719, 419059130@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corneal biomechanics (time frame: Baseline in all groups and after 3m medication in VKC group). 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 NCT04299399, which also lists 2 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 6 Mar 2020.