Superior Limbic KeratoconjunctivitisNCT02160327
The Role of Cytokines and Mast Cell in the Pathogenesis of SLK, Conjunctivochalasis, and Dry Eye
An observational study of Superior Limbic Keratoconjunctivitis and Conjunctivochalasis, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The specific aims of the the investigators studies are as follows: To collect the tear samples from patients with different ocular surface disorders, including SLK, conjunctivochalasis, and keratoconjunctivitis sicca (KCS). Read more about this study
- Who is it for?
- Ages 20 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Superior Limbic Keratoconjunctivitis, Conjunctivochalasis, Dry Eye
- How many people
- 105 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2014to Dec 2017
- 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 20 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Part I. Tear sample diagnosed as a patients of superior limbic keratoconjunctivitis (SLK) or conjunctivochalasis or keratoconjunctivitis sicca (KCS) Part II. Surgical conjunctiva specimen disease group: SLK or conjunctivochalasis patients refractory to medical treatment and receiving conjunctival resection surgery
Who may be able to join
- age 20-85 years old
- diagnosed as a patients of superior limbic keratoconjunctivitis (SLK) or conjunctivochalasis or keratoconjunctivitis sicca (KCS)
- age 20-85 years old
- disease group: SLK or conjunctivochalasis patients refractory to medical treatment and receiving conjunctival resection surgery
- control group: patients receiving retinal or cataract surgery with redundant conjunctiva after peritomy
Who cannot join
- pregnancy
- any ocular surgery within 3 months
- Part II. Surgical conjunctiva specimen
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Cytokines and Mast Cell in the Pathogenesis of Ocular Surface Inflammation Diseases Including Superior Limbic Keratoconjunctivitis, Conjunctivochalasis, and Dry Eye
The specific aims of the the investigators studies are as follows:
- To collect the tear samples from patients with different ocular surface disorders, including SLK, conjunctivochalasis, and keratoconjunctivitis sicca (KCS).
- To evaluate the differential expression of tear cytokines and pH values between different ocular surface disorders.
- To collect the surgical conjunctival specimens from the patients with SLK and conjunctivochalasis.
- To evaluate the factors inducing mast cell migration and how mast cell is activated in SLK via surgical specimens and cultivated fibroblast.
Read the detailed description
- Detection of various tear cytokine levels in patients with superior limbic keratoconjunctivitis, conjunctivochalasis, and keratoconjunctivitis sicca
- Basal tear samples will be collected atraumatically from the inferolateral tear meniscus by using glass capillary tubes. Care is taken to avoid touching the corneal and conjunctival surface. Approximately 30 μl of tear samples is obtained, and then the samples are centrifuged for 10 minutes at 1500 rpm (225g). Tear sample are placed in microtubes (Eppendorf) and stored at -70°C. IL-1β, IL-17, TNF-α, and IFN-γ levels will be measured by enzyme-linked immunosorbent assay kits.
- Immunohistochemistry stain method for conjunctival specimens - The conjunctiva will be collected from SLK and conjunctivochalasis patients who received superior and inferior bulbar conjunctival resection as needed. The redundant conjunctiva noted after peritomy during cataract or retinal surgery will be excised to serve as a normal control. The conjunctival specimens of all the SLK, conjunctivochalasis, and control groups are sent to the pathology department for routine paraffin embedding and hematoxylin and eosin staining. The surgical specimens are placed into 4% paraformaldehyde at 4 C for one to two days and then stored in 1% sodium phosphate buffer at 4 C. They then are embedded in paraffin. To enhance tissue adhesion, 5-micrometer thick sections are mounted on glass slides pre- treated with Vectabond (Vector Laboratories, Burlingame, California, USA). The paraffin sections are deparaffinized, rehydrated and washed with phosphate-buffered saline (PBS; pH 7.4). Antigen retrieval is performed by immerse the sections in 0.1% trypsin in water bath for 15 mins. The endogenous peroxidase activity is quenched by placing the slides in 3% hydrogen peroxide. The slides are then blocked with serum followed by incubation with primary antibodies. Primary antibodies (TSL and SCF) are incubated overnight at 4°C. Thereafter, incubation with biotin conjugated secondary antibody is performed at room temperature for 60 min. Further, incubation with avidin-biotin horseradish peroxidase complex is then performed at room temperature as well for 30 min using Vectastain elite® ABC kit (Vector labs, CA USA). The location where the enzyme is bound will be visualized by the addition of the substrate 3,3'-diaminobenzidine (DAKO, CA, USA), a chromogen which produces a brown insoluble precipitate. The sections are then counterstained with haematoxylin, which is followed by dehydration and mounting with Vecta Mount Mounting medium was used to evaluate the slides.
- Medical subject headings
- Dry Eye Syndromes
What is being measured
The primary outcome is the main question the study is designed to answer.
Tear cytokines change measured by ELISA
Measured: Tear will be collected before treatment, one month and six months follow-up visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Superior Limbic KeratoconjunctivitisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Time perspective
- Prospective
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fung-Rong Hu, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02160327
- Sponsor's protocol ID
- 201312127RINB
- Status last verified
- Jun 2014
- First submitted
- 27 May 2014
- Last updated
- 24 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Cytokines and Mast Cell in the Pathogenesis of Ocular Surface Inflammation Diseases Including Superior Limbic Keratoconjunctivitis, Conjunctivochalasis, and Dry Eye
- ClinicalTrials.gov ID
- NCT02160327
- Acronym / sponsor ID
- 201312127RINB
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 10 Jun 2014 (estimated)
- 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 specific aims of the the investigators studies are as follows:
- To collect the tear samples from patients with different ocular surface disorders, including SLK, conjunctivochalasis, and keratoconjunctivitis sicca (KCS).
- To evaluate the differential expression of tear cytokines and pH values between different ocular surface disorders.
- To collect the surgical conjunctival specimens from the patients with SLK and conjunctivochalasis.
- To evaluate the factors inducing mast cell migration and how mast cell is activated in SLK via surgical specimens and cultivated fibroblast.
Detailed description
- Detection of various tear cytokine levels in patients with superior limbic keratoconjunctivitis, conjunctivochalasis, and keratoconjunctivitis sicca
- Basal tear samples will be collected atraumatically from the inferolateral tear meniscus by using glass capillary tubes. Care is taken to avoid touching the corneal and conjunctival surface. Approximately 30 μl of tear samples is obtained, and then the samples are centrifuged for 10 minutes at 1500 rpm (225g). Tear sample are placed in microtubes (Eppendorf) and stored at -70°C. IL-1β, IL-17, TNF-α, and IFN-γ levels will be measured by enzyme-linked immunosorbent assay kits.
- Immunohistochemistry stain method for conjunctival specimens - The conjunctiva will be collected from SLK and conjunctivochalasis patients who received superior and inferior bulbar conjunctival resection as needed. The redundant conjunctiva noted after peritomy during cataract or retinal surgery will be excised to serve as a normal control. The conjunctival specimens of all the SLK, conjunctivochalasis, and control groups are sent to the pathology department for routine paraffin embedding and hematoxylin and eosin staining. The surgical specimens are placed into 4% paraformaldehyde at 4 C for one to two days and then stored in 1% sodium phosphate buffer at 4 C. They then are embedded in paraffin. To enhance tissue adhesion, 5-micrometer thick sections are mounted on glass slides pre- treated with Vectabond (Vector Laboratories, Burlingame, California, USA). The paraffin sections are deparaffinized, rehydrated and washed with phosphate-buffered saline (PBS; pH 7.4). Antigen retrieval is performed by immerse the sections in 0.1% trypsin in water bath for 15 mins. The endogenous peroxidase activity is quenched by placing the slides in 3% hydrogen peroxide. The slides are then blocked with serum followed by incubation with primary antibodies. Primary antibodies (TSL and SCF) are incubated overnight at 4°C. Thereafter, incubation with biotin conjugated secondary antibody is performed at room temperature for 60 min. Further, incubation with avidin-biotin horseradish peroxidase complex is then performed at room temperature as well for 30 min using Vectastain elite® ABC kit (Vector labs, CA USA). The location where the enzyme is bound will be visualized by the addition of the substrate 3,3'-diaminobenzidine (DAKO, CA, USA), a chromogen which produces a brown insoluble precipitate. The sections are then counterstained with haematoxylin, which is followed by dehydration and mounting with Vecta Mount Mounting medium was used to evaluate the slides.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Part I. Tear sample diagnosed as a patients of superior limbic keratoconjunctivitis (SLK) or conjunctivochalasis or keratoconjunctivitis sicca (KCS) Part II. Surgical conjunctiva specimen disease group: SLK or conjunctivochalasis patients refractory to medical treatment and receiving conjunctival resection surgery
Key inclusion criteria (5 listed)
- age 20-85 years old
- diagnosed as a patients of superior limbic keratoconjunctivitis (SLK) or conjunctivochalasis or keratoconjunctivitis sicca (KCS)
- age 20-85 years old
- disease group: SLK or conjunctivochalasis patients refractory to medical treatment and receiving conjunctival resection surgery
- control group: patients receiving retinal or cataract surgery with redundant conjunctiva after peritomy
Key exclusion criteria (3 listed)
- pregnancy
- any ocular surgery within 3 months
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
Tear cytokines change measured by ELISA
Time frame: Tear will be collected before treatment, one month and six months follow-up visits
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2014.
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.
Fung-Rong Hu, MD principal investigator
National Taiwan University Hospital
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 Superior Limbic Keratoconjunctivitis and Conjunctivochalasis, run by National Taiwan University Hospital at 1 site in Taiwan.
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 5 inclusion and 3 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 24 Jun 2014. 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 Taiwan. 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?
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?
Tear cytokines change measured by ELISA (time frame: Tear will be collected before treatment, one month and six months follow-up visits). 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 24 Jun 2014.