Dry Eye SyndromesPhase 4NCT03747614
Ocular Micro-vascular Research Base on Functional Slip Lamp Biomicroscopy
A Phase 4 study testing Fluorometholone and Functional Slit-Lamp Biomicroscopy in people with Dry Eye Syndromes and Inflammation, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial summary
Dry eye disease (DED), as one of the most common ocular surface diseases that affecting visual acuity, is highly associated with ocular surface inflammation. Until now, there is no accurate quantization index system to evaluate real-time ocular surface inflammation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Syndromes, Inflammation, Microvessels
- What is being tested?
- Fluorometholone and Functional Slit-Lamp Biomicroscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2017to 30 Jun 2020
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age ≧ 18 years
- Ocular Surface Disease Index (OSDI) ≧ 12.
- A 5-min Schirmer I test (ST) result showing less than 5 mm of moisture on the strip.
- A noninvasive average tear-film break-up time (NI-avBUT) less than 5 s.
Who cannot join
- Patients were excluded if they had an eye infection, injury, non-DE ocular inflammation, ocular surgery within the last 6 months, or any concurrent treatment that might interfere with the interpretation of the study results (systemic corticosteroids, immunosuppressive therapy, or hormonal replacement therapy). Patients were also excluded if they had an uncontrolled disease, had a significant illness or were pregnant or lactating.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Wan Chen
Guangzhou, Guangdong, 510060
Wan Chen, 13751770265, yeah-cw@126.com
Lulu Peng, 15622263892, 15622263892@163.com
About this study
Dry eye disease (DED), as one of the most common ocular surface diseases that affecting visual acuity, is highly associated with ocular surface inflammation. Until now, there is no accurate quantization index system to evaluate real-time ocular surface inflammation. Besides, an individualized therapy for ocular surface inflammation is also badly needed. As we all know, conjunctival congestion is one of the important clinical appearance of ocular surface inflammation. Hence, we suggest that several specific microvascular indexes could measure the change of ocular surface inflammation. Our program is aiming to investigate the correlation between inflammatory factors and blood flow velocity as well as microvascular distribution detecting from bulbar conjunctiva through our own devices and software.Futhermore, we tend to compare ocular surface microvascular indexes and microvascular distribution in normal people and dry eye patients in order to establish a database for Chinese people. By confirming the relationship between ocular surface microvascular indexes and ocular inflammation, we hope to set up new diagnostic criteria for ocular inflammation and an individualized therapeutic regimen based on ocular surface microvascular indexes. Finally, we want to establish a precision diagnostic and therapeutic pattern for dry eye disease.
Read the detailed description
Dry eye (DE) is a growing public health concern that affects not only the visual function but also the quality of life of patients. In 2017, the International DE Study Workshop (DEWSII) adjusted the definition of DE by particularly emphasizing the inflammation in the ocular surface, and this adjustment represented a major shift in the understanding of dry eye disease (DED) pathogenesis and the facilitation of DED treatment.1,2 The recurrence of chronic and low-grade inflammation plays an important role in long-term disease progression and gradually deteriorates the ocular surface.3 Previous studies have concluded that the inflammatory response is involved in the pathological process of DE.4-7 The concentrations of IL-1α and mature IL-1ß in the tear fluid are increased.4,5 The activity of MMP-9, a suggested biomarker associated with ocular surface diseases including DE, is significantly elevated in Meibomian gland dysfunction (MGD), Sjögren's syndrome (SS) and aqueous tear deficiency (ATD).6 Other studies have indicated that inflammatory mediators such as IL-6, IL-8 and TNFα are expressed proportionally to the severity of DE symptoms, indicating the involvement of inflammation.7 The identification of inflammation as a major factor in DE informs the treatment strategy, including anti-inflammatory medication, which results in improvements to the ocular surface condition and to ocular comfort in DED patients.8,9 A series of studies have demonstrated improvements in the subjective and objective signs and symptoms of DE after anti-inflammatory and immunomodulatory therapies.8-11 To monitor the status of ocular surface inflammation and the ocular surface condition, traditional assessments, namely, evaluation of conjunctival hyperemia12 and corneal fluorescein staining using a slit lamp biomicroscope, are used. However, these methods are subjective and volatile and may not be sensitive indicators of the disease stage and treatment efficacy.13 A number of new tests have been used to distinguish inflammation.13-15 These new technologies include corneal confocal microscopy,15 conjunctival impression cytology16 and inflammatory tear-film cytokine tests in research and in the clinic.17 These newly implemented techniques have several limitations. Corneal confocal microscopy is a structure-based instrument with a narrow view of 400 × 400 µm2 that is limited to localization and cell counting. Conjunctival impression cytology16 and inflammatory tear-film cytokine tests19 are not routinely used, possibly due to the invasiveness, high cost and discomfort of these techniques.5,18 Therefore, the development of new methodologies to noninvasively and subjectively evaluate the inflammation status of the ocular surface is crucial.
The microvascular system of the bulbar conjunctiva can be easily accessed. The release of inflammatory cytokines on the ocular surface can cause vasodilation, which may result in alterations to the conjunctival microcirculation.19 Cheung et al. used a computer-assisted intravital microscope to evaluate vasculopathies of the conjunctival vessels and identified microvascular abnormalities in patients with diabetes20 and in patients who wore contact lens.21 Schulze et al. have also performed 'evaluations of the redness of the bulbar conjunctiva using fractal analysis and photometry.22 However, these studies did not directly measure the microcirculation. The microcirculation is an important aspect of the vascular system, may directly represent the hemodynamic response to ocular surface inflammation and may exhibit more sensitivity for monitoring vascular responses to anti-inflammatory treatment. Recently, Jiang et al. developed a functional slit-lamp biomicroscope that could be used to measure the conjunctival blood flow velocity (BFV) and vessel diameter.23 The goal of the present study was to characterize the microvasculature and microcirculation in the bulbar conjunctiva of DE patients in response to anti-inflammatory treatment.
- Conditions
- Dry Eye Syndromes, Inflammation, Microvessels
- Being tested
- Fluorometholone, Functional Slit-Lamp Biomicroscopy
- Medical subject headings
- Dry Eye Syndromes, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluorometholoneDrug
Also called Tacrolimus
Fluorometh010neEyeDrops:
Brand names: Allergan Pharmaceuticals Ireland, Serial number: J20130061, NDC 60758-880-05. Tacrolimus Brand names: Senju Pharmaceutical Co., Ltd. Fukusaki Plant Serial number: H20130452
Functional Slit-Lamp BiomicroscopyDevice
A traditional slit lamp (HAAG-STREIT SWISS MADE 900.7.2.34925) was used, and a digital camera (Canon 60D. Canon Inc, Melville, NY) was attached via an inherent camera port. Custom software was used to measure the conjunctival microvascular BFV and vessel diameter using a protocol that has been previously described in detail. At baseline, video clips were recorded on six fields of the bulbar conjunctiva, which was approximately 1 mm from the limbus. During the follow-up visits, attention was given to relocating the vessel segments for these 6 fields.
| Study group | Role | What they receive |
|---|---|---|
| Dry eye group | Experimental | The recruitment of subjects met the criteria of DEWS. Each subject received treatment based on increasing severity according to the expert consensus for the treatment of DE inflammation. For moderate levels of severity, topical anti-inflammatory agents (0.1% Fluorometholone) were administered twice daily and then gradually less frequently until inflammation was controlled. For severe DE, the approach was similar to that of the moderate level but with an increased concentration and treatment frequency of the anti-inflammatory agents (0.1% Fluorometholone, 4 times daily). Topical 0.05% tacrolimus twice daily when DE was extremely severe. Functional Slit-Lamp Biomicroscopy were administrated to collected data from this group. Receives: Drug: Fluorometholone; Device: Functional Slit-Lamp Biomicroscopy |
| Control group | Experimental | Normal health subject without drug intervention, Functional Slit-Lamp Biomicroscopy were administrated to collected data from this group. Receives: Device: Functional Slit-Lamp Biomicroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conjunctival microvascular blood flow velocity
Acheived by a traditional slit lamp (HAAG-STREIT SWISS MADE 900.7.2.34925) with a digital camera (Canon 60D. Canon Inc, Melville, NY) and a custom software.
Measured: Baseline
Conjunctival microvascular blood flow velocity
Acheived by a traditional slit lamp (HAAG-STREIT SWISS MADE 900.7.2.34925) with a digital camera (Canon 60D. Canon Inc, Melville, NY) and a custom software.
Measured: 30 days after commencement of treatment
Conjunctival microvascular blood flow velocity
Acheived by a traditional slit lamp (HAAG-STREIT SWISS MADE 900.7.2.34925) with a digital camera (Canon 60D. Canon Inc, Melville, NY) and a custom software.
Measured: 60 days after commencement of treatment
Conjunctival microvascular diameter
Acheived by a traditional slit lamp (HAAG-STREIT SWISS MADE 900.7.2.34925) with a digital camera (Canon 60D. Canon Inc, Melville, NY) and a custom software.
Measured: Baseline
Conjunctival microvascular diameter
Acheived by a traditional slit lamp (HAAG-STREIT SWISS MADE 900.7.2.34925) with a digital camera (Canon 60D. Canon Inc, Melville, NY) and a custom software.
Measured: 30 days after commencement of treatment
Conjunctival microvascular diameter
Acheived by a traditional slit lamp (HAAG-STREIT SWISS MADE 900.7.2.34925) with a digital camera (Canon 60D. Canon Inc, Melville, NY) and a custom software.
Measured: 60 days after commencement of treatment
Conjunctival microvascular blood flow rate
Acheived by a traditional slit lamp (HAAG-STREIT SWISS MADE 900.7.2.34925) with a digital camera (Canon 60D. Canon Inc, Melville, NY) and a custom software.
Measured: Baseline
Conjunctival microvascular blood flow rate
Acheived by a traditional slit lamp (HAAG-STREIT SWISS MADE 900.7.2.34925) with a digital camera (Canon 60D. Canon Inc, Melville, NY) and a custom software.
Measured: 30 days after commencement of treatment
Conjunctival microvascular blood flow rate
Acheived by a traditional slit lamp (HAAG-STREIT SWISS MADE 900.7.2.34925) with a digital camera (Canon 60D. Canon Inc, Melville, NY) and a custom software.
Measured: 60 days after commencement of treatment
The hyperemia index
The hyperemia index (HI) was measured by determining the percentage of conjunctival microvascular area in the conjunctiva automatically.26 The subjects were required to keep their eyes open and focus on the illuminated ring in front. Three consecutive readings were recorded, and the median was used. All data were recorded and analyzed with TF-scan software in the system.
Measured: Baseline
The hyperemia index
The hyperemia index (HI) was measured by determining the percentage of conjunctival microvascular area in the conjunctiva automatically.26 The subjects were required to keep their eyes open and focus on the illuminated ring in front. Three consecutive readings were recorded, and the median was used. All data were recorded and analyzed with TF-scan software in the system.
Measured: 30 days after commencement of treatment
The hyperemia index
The hyperemia index (HI) was measured by determining the percentage of conjunctival microvascular area in the conjunctiva automatically.26 The subjects were required to keep their eyes open and focus on the illuminated ring in front. Three consecutive readings were recorded, and the median was used. All data were recorded and analyzed with TF-scan software in the system.
Measured: 60 days after commencement of treatment
Secondary outcomes (9)
Non-invasived tear-film break-up time
The system measures the tear-film break-up time (NI-BUT) by monitoring the Placido projection on the cornea and includes the noninvasive first tear-film break-up time (NI-fBUT) and NI-avBUT. NI-fBUT and NI-avBUT were the measured times of the first and half-area breaks in the tear film between the full opening of the eyelids after 2 complete blinks.
Measured: Baseline
Non-invasived tear-film break-up time
The system measures the tear-film break-up time (NI-BUT) by monitoring the Placido projection on the cornea and includes the noninvasive first tear-film break-up time (NI-fBUT) and NI-avBUT. NI-fBUT and NI-avBUT were the measured times of the first and half-area breaks in the tear film between the full opening of the eyelids after 2 complete blinks.
Measured: 30 days after commencement of treatment
Non-invasived tear-film break-up time
The system measures the tear-film break-up time (NI-BUT) by monitoring the Placido projection on the cornea and includes the noninvasive first tear-film break-up time (NI-fBUT) and NI-avBUT. NI-fBUT and NI-avBUT were the measured times of the first and half-area breaks in the tear film between the full opening of the eyelids after 2 complete blinks.
Measured: 60 days after commencement of treatment
Corneal Fluorescein Staining
Fluorescein was administered into the conjunctival sac under a cobalt blue light from the slit lamp. Corneal epithelial cell disruption was measured via corneal staining (National Eye Institute (NEI) scale, 5 areas of the cornea assessed (central, temporal, nasal, superior, and inferior), and the scores were assigned per a 0-8 scale for each area (total 40). Tear production was measured with Schirmer strips without anesthesia.
Measured: Baseline
Corneal Fluorescein Staining
Fluorescein was administered into the conjunctival sac under a cobalt blue light from the slit lamp. Corneal epithelial cell disruption was measured via corneal staining (National Eye Institute (NEI) scale, 5 areas of the cornea assessed (central, temporal, nasal, superior, and inferior), and the scores were assigned per a 0-8 scale for each area (total 40). Tear production was measured with Schirmer strips without anesthesia.
Measured: 30 days after commencement of treatment
Corneal Fluorescein Staining
Fluorescein was administered into the conjunctival sac under a cobalt blue light from the slit lamp. Corneal epithelial cell disruption was measured via corneal staining (National Eye Institute (NEI) scale, 5 areas of the cornea assessed (central, temporal, nasal, superior, and inferior), and the scores were assigned per a 0-8 scale for each area (total 40). Tear production was measured with Schirmer strips without anesthesia.
Measured: 60 days after commencement of treatment
Schirmer I test
A meansurement of tear production with Schirmer strips and anaesthesia.
Measured: Baseline
Schirmer I test
A meansurement of tear production with Schirmer strips and anaesthesia.
Measured: 30 days after commencement of treatment
Schirmer I test
A meansurement of tear production with Schirmer strips and anaesthesia.
Measured: 60 days after commencement of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start30 Jun 2017
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- subjects from zhongshan ophthalmic center
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Yuan, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03747614
- Sponsor's protocol ID
- 81670826
- Status last verified
- Nov 2018
- First submitted
- 30 Nov 2017
- Last updated
- 20 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ocular Micro-vascular Research Base on Functional Slip Lamp Biomicroscopy
- ClinicalTrials.gov ID
- NCT03747614
- Acronym / sponsor ID
- 81670826
- Conditions
- Dry Eye Syndromes, Inflammation, Microvessels
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 30 Jun 2017 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 20 Nov 2018 (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.
Dry eye disease (DED), as one of the most common ocular surface diseases that affecting visual acuity, is highly associated with ocular surface inflammation. Until now, there is no accurate quantization index system to evaluate real-time ocular surface inflammation. Besides, an individualized therapy for ocular surface inflammation is also badly needed. As we all know, conjunctival congestion is one of the important clinical appearance of ocular surface inflammation. Hence, we suggest that several specific microvascular indexes could measure the change of ocular surface inflammation. Our program is aiming to investigate the correlation between inflammatory factors and blood flow velocity as well as microvascular distribution detecting from bulbar conjunctiva through our own devices and software.Futhermore, we tend to compare ocular surface microvascular indexes and microvascular distribution in normal people and dry eye patients in order to establish a database for Chinese people. By confirming the relationship between ocular surface microvascular indexes and ocular inflammation, we hope to set up new diagnostic criteria for ocular inflammation and an individualized therapeutic regimen based on ocular surface microvascular indexes. Finally, we want to establish a precision diagnostic and therapeutic pattern for dry eye disease.
Detailed description
Dry eye (DE) is a growing public health concern that affects not only the visual function but also the quality of life of patients. In 2017, the International DE Study Workshop (DEWSII) adjusted the definition of DE by particularly emphasizing the inflammation in the ocular surface, and this adjustment represented a major shift in the understanding of dry eye disease (DED) pathogenesis and the facilitation of DED treatment.1,2 The recurrence of chronic and low-grade inflammation plays an important role in long-term disease progression and gradually deteriorates the ocular surface.3 Previous studies have concluded that the inflammatory response is involved in the pathological process of DE.4-7 The concentrations of IL-1α and mature IL-1ß in the tear fluid are increased.4,5 The activity of MMP-9, a suggested biomarker associated with ocular surface diseases including DE, is significantly elevated in Meibomian gland dysfunction (MGD), Sjögren's syndrome (SS) and aqueous tear deficiency (ATD).6 Other studies have indicated that inflammatory mediators such as IL-6, IL-8 and TNFα are expressed proportionally to the severity of DE symptoms, indicating the involvement of inflammation.7 The identification of inflammation as a major factor in DE informs the treatment strategy, including anti-inflammatory medication, which results in improvements to the ocular surface condition and to ocular comfort in DED patients.8,9 A series of studies have demonstrated improvements in the subjective and objective signs and symptoms of DE after anti-inflammatory and immunomodulatory therapies.8-11 To monitor the status of ocular surface inflammation and the ocular surface condition, traditional assessments, namely, evaluation of conjunctival hyperemia12 and corneal fluorescein staining using a slit lamp biomicroscope, are used. However, these methods are subjective and volatile and may not be sensitive indicators of the disease stage and treatment efficacy.13 A number of new tests have been used to distinguish inflammation.13-15 These new technologies include corneal confocal microscopy,15 conjunctival impression cytology16 and inflammatory tear-film cytokine tests in research and in the clinic.17 These newly implemented techniques have several limitations. Corneal confocal microscopy is a structure-based instrument with a narrow view of 400 × 400 µm2 that is limited to localization and cell counting. Conjunctival impression cytology16 and inflammatory tear-film cytokine tests19 are not routinely used, possibly due to the invasiveness, high cost and discomfort of these techniques.5,18 Therefore, the development of new methodologies to noninvasively and subjectively evaluate the inflammation status of the ocular surface is crucial.
The microvascular system of the bulbar conjunctiva can be easily accessed. The release of inflammatory cytokines on the ocular surface can cause vasodilation, which may result in alterations to the conjunctival microcirculation.19 Cheung et al. used a computer-assisted intravital microscope to evaluate vasculopathies of the conjunctival vessels and identified microvascular abnormalities in patients with diabetes20 and in patients who wore contact lens.21 Schulze et al. have also performed 'evaluations of the redness of the bulbar conjunctiva using fractal analysis and photometry.22 However, these studies did not directly measure the microcirculation. The microcirculation is an important aspect of the vascular system, may directly represent the hemodynamic response to ocular surface inflammation and may exhibit more sensitivity for monitoring vascular responses to anti-inflammatory treatment. Recently, Jiang et al. developed a functional slit-lamp biomicroscope that could be used to measure the conjunctival blood flow velocity (BFV) and vessel diameter.23 The goal of the present study was to characterize the microvasculature and microcirculation in the bulbar conjunctiva of DE patients in response to anti-inflammatory treatment.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- subjects from zhongshan ophthalmic center
| Arm | Type | Receives |
|---|---|---|
| Dry eye group | Experimental | Drug: Fluorometholone, Device: Functional Slit-Lamp BiomicroscopyThe recruitment of subjects met the criteria of DEWS. Each subject received treatment based on increasing severity according to the expert consensus for the treatment of DE inflammation. For moderate levels of severity, topical anti-inflammatory agents (0.1% Fluorometholone) were administered twice daily and then gradually less frequently until inflammation was controlled. For severe DE, the approach was similar to that of the moderate level but with an increased concentration and treatment frequency of the anti-inflammatory agents (0.1% Fluorometholone, 4 times daily). Topical 0.05% tacrolimus twice daily when DE was extremely severe. Functional Slit-Lamp Biomicroscopy were administrated to collected data from this group. |
| Control group | Experimental | Device: Functional Slit-Lamp BiomicroscopyNormal health subject without drug intervention, Functional Slit-Lamp Biomicroscopy were administrated to collected data from this group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age ≧ 18 years
- Ocular Surface Disease Index (OSDI) ≧ 12.
- A 5-min Schirmer I test (ST) result showing less than 5 mm of moisture on the strip.
- A noninvasive average tear-film break-up time (NI-avBUT) less than 5 s.
Key exclusion criteria (1 listed)
- Patients were excluded if they had an eye infection, injury, non-DE ocular inflammation, ocular surgery within the last 6 months, or any concurrent treatment that might interfere with the interpretation of the study results (systemic corticosteroids, immunosuppressive therapy, or hormonal replacement therapy). Patients were also excluded if they had an uncontrolled disease, had a significant illness or were pregnant or lactating.
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 |
|---|---|---|
| FluorometholoneAlso: TacrolimusFluorometh010neEyeDrops: Brand names: Allergan Pharmaceuticals Ireland, Serial number: J20130061, NDC 60758-880-05. Tacrolimus Brand names: Senju Pharmaceutical Co., Ltd. Fukusaki Plant Serial number: H20130452 | Drug | Dry eye group |
| Functional Slit-Lamp BiomicroscopyA traditional slit lamp (HAAG-STREIT SWISS MADE 900.7.2.34925) was used, and a digital camera (Canon 60D. Canon Inc, Melville, NY) was attached via an inherent camera port. Custom software was used to measure the conjunctival microvascular BFV and vessel diameter using a protocol that has been previously described in detail. At baseline, video clips were recorded on six fields of the bulbar conjunctiva, which was approximately 1 mm from the limbus. During the follow-up visits, attention was given to relocating the vessel segments for these 6 fields. | Device | Control group, Dry eye group |
Primary outcome
Conjunctival microvascular blood flow velocity
Time frame: Baseline
Acheived by a traditional slit lamp (HAAG-STREIT SWISS MADE 900.7.2.34925) with a digital camera (Canon 60D. Canon Inc, Melville, NY) and a custom software.
Conjunctival microvascular blood flow velocity
Time frame: 30 days after commencement of treatment
Acheived by a traditional slit lamp (HAAG-STREIT SWISS MADE 900.7.2.34925) with a digital camera (Canon 60D. Canon Inc, Melville, NY) and a custom software.
Conjunctival microvascular blood flow velocity
Time frame: 60 days after commencement of treatment
Acheived by a traditional slit lamp (HAAG-STREIT SWISS MADE 900.7.2.34925) with a digital camera (Canon 60D. Canon Inc, Melville, NY) and a custom software.
Conjunctival microvascular diameter
Time frame: Baseline
Acheived by a traditional slit lamp (HAAG-STREIT SWISS MADE 900.7.2.34925) with a digital camera (Canon 60D. Canon Inc, Melville, NY) and a custom software.
Conjunctival microvascular diameter
Time frame: 30 days after commencement of treatment
Acheived by a traditional slit lamp (HAAG-STREIT SWISS MADE 900.7.2.34925) with a digital camera (Canon 60D. Canon Inc, Melville, NY) and a custom software.
Conjunctival microvascular diameter
Time frame: 60 days after commencement of treatment
Acheived by a traditional slit lamp (HAAG-STREIT SWISS MADE 900.7.2.34925) with a digital camera (Canon 60D. Canon Inc, Melville, NY) and a custom software.
Conjunctival microvascular blood flow rate
Time frame: Baseline
Acheived by a traditional slit lamp (HAAG-STREIT SWISS MADE 900.7.2.34925) with a digital camera (Canon 60D. Canon Inc, Melville, NY) and a custom software.
Conjunctival microvascular blood flow rate
Time frame: 30 days after commencement of treatment
Acheived by a traditional slit lamp (HAAG-STREIT SWISS MADE 900.7.2.34925) with a digital camera (Canon 60D. Canon Inc, Melville, NY) and a custom software.
Conjunctival microvascular blood flow rate
Time frame: 60 days after commencement of treatment
Acheived by a traditional slit lamp (HAAG-STREIT SWISS MADE 900.7.2.34925) with a digital camera (Canon 60D. Canon Inc, Melville, NY) and a custom software.
The hyperemia index
Time frame: Baseline
The hyperemia index (HI) was measured by determining the percentage of conjunctival microvascular area in the conjunctiva automatically.26 The subjects were required to keep their eyes open and focus on the illuminated ring in front. Three consecutive readings were recorded, and the median was used. All data were recorded and analyzed with TF-scan software in the system.
The hyperemia index
Time frame: 30 days after commencement of treatment
The hyperemia index (HI) was measured by determining the percentage of conjunctival microvascular area in the conjunctiva automatically.26 The subjects were required to keep their eyes open and focus on the illuminated ring in front. Three consecutive readings were recorded, and the median was used. All data were recorded and analyzed with TF-scan software in the system.
The hyperemia index
Time frame: 60 days after commencement of treatment
The hyperemia index (HI) was measured by determining the percentage of conjunctival microvascular area in the conjunctiva automatically.26 The subjects were required to keep their eyes open and focus on the illuminated ring in front. Three consecutive readings were recorded, and the median was used. All data were recorded and analyzed with TF-scan software in the system.
9 secondary outcomes
Non-invasived tear-film break-up time
Time frame: Baseline
Non-invasived tear-film break-up time
Time frame: 30 days after commencement of treatment
Non-invasived tear-film break-up time
Time frame: 60 days after commencement of treatment
Corneal Fluorescein Staining
Time frame: Baseline
Corneal Fluorescein Staining
Time frame: 30 days after commencement of treatment
Corneal Fluorescein Staining
Time frame: 60 days after commencement of treatment
Schirmer I test
Time frame: Baseline
Schirmer I test
Time frame: 30 days after commencement of treatment
Schirmer I test
Time frame: 60 days after commencement of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluorometholone and Functional Slit-Lamp Biomicroscopy in people with Dry Eye Syndromes and Inflammation, 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 4 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: status not confirmed, as of the sponsor's last update on 20 Nov 2018. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jin Yuan, PHD (13825141659, yuanjincornea@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conjunctival microvascular blood flow velocity (time frame: Baseline). The study lists 12 primary outcomes in all. 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 20 Nov 2018.