Ocular Micro-vascular Research Base on Functional Slip Lamp Biomicroscopy

NCT03747614 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: 81670826
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Dry Eye Syndromes; Inflammation; Microvessels

Outcome Measures

Primary Outcomes (12)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  60 days after commencement of treatment

Secondary Outcomes (9)

• Non-invasived tear-film break-up time

  Baseline

• Non-invasived tear-film break-up time

  30 days after commencement of treatment

• Non-invasived tear-film break-up time

  60 days after commencement of treatment

• Corneal Fluorescein Staining

  Baseline

• Corneal Fluorescein Staining

  30 days after commencement of treatment

Study Arms (2)

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.

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.

Device: Functional Slit-Lamp Biomicroscopy

Interventions

Fluorometholone DRUG

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

Also known as: Tacrolimus

Dry eye group

Functional Slit-Lamp Biomicroscopy DEVICE

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.

Control group; Dry eye group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The participant eligibility is based on self-representation of gender identity.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

Study Sites (1)

Wan Chen

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes; Inflammation

Interventions

Fluorometholone; Tacrolimus

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Macrolides; Lactones; Organic Chemicals

Central Study Contacts

Jin Yuan, PHD

CONTACT

13825141659; yuanjincornea@126.com

YUQING DENG

CONTACT

18120557291; 15927646647@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: subjects from zhongshan ophthalmic center

Study Record Dates

• First Submitted: November 30, 2017
• First Posted: November 20, 2018
• Study Start: June 30, 2017
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: November 20, 2018

Record last verified: 2018-11

Locations

CN (1)