CataractNCT05511506
Cytokines in Femtosecond Laser-assisted Cataract Surgery
A study testing aqueous humor collection in people with Cataract, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The investigators performed the current study to compare: 1) the pain scores by Visual Analogue Scale; 2) the cytokines concentrations in aqueous humor by human cytokine antibody array; 3) the prostaglandin E2 (PGE2) concentrations by enzyme linked immunosorbent assay (ELISA); 4) the pupil behaviors by Image J between… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Cataract
- What is being tested?
- aqueous humor collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 30 Jun 2022
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consecutive cataract patients aged 40-80 years, regardless of gender, with bilateral similar grades of lens opacity, and scheduled for sequential FLACS were enrolled in this study.
Who cannot join
- history of ocular or systematic inflammatory diseases like uveitis, rheumatism or other autoimmune diseases;
- previous ocular surgery or trauma;
- preoperative glaucoma, zonular weakness, lens dislocation, or poor pupil dilation (measured pupil diameter <5.0 mm) or synechiae;
- use of systemic or topical steroids, non-steroidal anti-inflammatory drugs (NSAIDs), alpha-adrenergic antagonist, or pain relief medications within 1 month prior to surgery;
- patients with baseline eye pain, having anxiety, muscle spasm around the eye or involuntary eye movement disorders which may influence the pain score;
- eyes needing for any other type of anesthesia, failed to obtain > 100 μl aqueous humor (AH) or encountered intra-operative complications like posterior capsule rupture
Trial locations and contacts
1 site in 1 country.
China1 site
Second Affiliated Hospital, Medical College of Zhejiang University, Hangzhou, China
Hangzhou
About this study
Official title: Comparison Between Cytokines During First and Second Eye Surgeries in Patients With Bilateral Femtosecond Laser-assisted Cataract Surgery
The investigators performed the current study to compare: 1) the pain scores by Visual Analogue Scale; 2) the cytokines concentrations in aqueous humor by human cytokine antibody array; 3) the prostaglandin E2 (PGE2) concentrations by enzyme linked immunosorbent assay (ELISA); 4) the pupil behaviors by Image J between first-eye and second-eye in bilateral cataract patients undergoing sequential femtosecond laser-assisted cataract surgery (FLACS). To our knowledge, this is the first intraindividual study investigating contralateral effect in FLACS. The findings from the current study may broaden our understanding on the mechanism of sympathetic reaction, help to improve clinical performances, and provide strong clinical guidance for cataract surgeons.
- Conditions
- Cataract
- Being tested
- aqueous humor collection
- Keywords
- cataract; cytokine; pain; miosis
- Medical subject headings
- Cataract, Pain, Miosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aqueous humor collectionOther
Once the laser procedures were finished, the patient was transported to another surgery operating bed. Before the eyeball was opened, 100-200 μL of aqueous humor was obtained from the anterior chamber via an ultra-thin needle through the paracentesis site of cornea.
| Study group | Role | What they receive |
|---|---|---|
| first-eye group | Other | Not described Receives: Other: aqueous humor collection |
| second-eye group | Other | Not described Receives: Other: aqueous humor collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain scores
pain scores of of eyes undergoing sequential FLACS by Visual Analogue Scale (VAS) scoring system, presenting as a numbered line ranging from 0 (no pain) to 10 (unbearable pain) for the severity of ever experienced pain was used. Higher scores mean a worse outcome.
Measured: through study completion, an average of 1 year
cytokines concentrations
Aqueous PGE2 concentrations were determined by using a commercially available Prostaglandin E2 Parameter ELISA Kit (USA R\&D Systems, Inc) in accordance with the manufacturer's protocol. Concentrations of 6 selected cytokines (interleukins (IL-1β, IL-1ra, IL-6, IL-8), monocyte chemotactic protein(MCP-1), tumor necrosis factor-α (TNF-α) in aqueous humor were simultaneously measured using Human Luminex Discovery Assay Multiplex Kits (USA R\&D Systems, Inc) by using methods that had been previously described.
Measured: through study completion, an average of 1 year
pupil behaviors
the pupil behaviors by Image J between first-eye and second-eye in bilateral cataract patients undergoing sequential FLACS
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start1 Jan 2022
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- yu yinhui, MD, Principal investigator, Second Affiliated Hospital, Medical College of Zhejiang University, Hangzhou, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05511506
- Sponsor's protocol ID
- 2022-0473
- Status last verified
- Jan 2022
- First submitted
- 11 Aug 2022
- Last updated
- 23 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Cytokines During First and Second Eye Surgeries in Patients With Bilateral Femtosecond Laser-assisted Cataract Surgery
- ClinicalTrials.gov ID
- NCT05511506
- Acronym / sponsor ID
- 2022-0473
- Conditions
- Cataract
- Keywords
- cataract; cytokine; pain; miosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 23 Aug 2022 (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 investigators performed the current study to compare: 1) the pain scores by Visual Analogue Scale; 2) the cytokines concentrations in aqueous humor by human cytokine antibody array; 3) the prostaglandin E2 (PGE2) concentrations by enzyme linked immunosorbent assay (ELISA); 4) the pupil behaviors by Image J between first-eye and second-eye in bilateral cataract patients undergoing sequential femtosecond laser-assisted cataract surgery (FLACS). To our knowledge, this is the first intraindividual study investigating contralateral effect in FLACS. The findings from the current study may broaden our understanding on the mechanism of sympathetic reaction, help to improve clinical performances, and provide strong clinical guidance for cataract surgeons.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| first-eye group | Other | Other: aqueous humor collection |
| second-eye group | Other | Other: aqueous humor collection |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consecutive cataract patients aged 40-80 years, regardless of gender, with bilateral similar grades of lens opacity, and scheduled for sequential FLACS were enrolled in this study.
Key exclusion criteria (6 listed)
- history of ocular or systematic inflammatory diseases like uveitis, rheumatism or other autoimmune diseases;
- previous ocular surgery or trauma;
- preoperative glaucoma, zonular weakness, lens dislocation, or poor pupil dilation (measured pupil diameter <5.0 mm) or synechiae;
- use of systemic or topical steroids, non-steroidal anti-inflammatory drugs (NSAIDs), alpha-adrenergic antagonist, or pain relief medications within 1 month prior to surgery;
- patients with baseline eye pain, having anxiety, muscle spasm around the eye or involuntary eye movement disorders which may influence the pain score;
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 |
|---|---|---|
| aqueous humor collectionOnce the laser procedures were finished, the patient was transported to another surgery operating bed. Before the eyeball was opened, 100-200 μL of aqueous humor was obtained from the anterior chamber via an ultra-thin needle through the paracentesis site of cornea. | Other | first-eye group, second-eye group |
Primary outcome
pain scores
Time frame: through study completion, an average of 1 year
pain scores of of eyes undergoing sequential FLACS by Visual Analogue Scale (VAS) scoring system, presenting as a numbered line ranging from 0 (no pain) to 10 (unbearable pain) for the severity of ever experienced pain was used. Higher scores mean a worse outcome.
cytokines concentrations
Time frame: through study completion, an average of 1 year
Aqueous PGE2 concentrations were determined by using a commercially available Prostaglandin E2 Parameter ELISA Kit (USA R\&D Systems, Inc) in accordance with the manufacturer's protocol. Concentrations of 6 selected cytokines (interleukins (IL-1β, IL-1ra, IL-6, IL-8), monocyte chemotactic protein(MCP-1), tumor necrosis factor-α (TNF-α) in aqueous humor were simultaneously measured using Human Luminex Discovery Assay Multiplex Kits (USA R\&D Systems, Inc) by using methods that had been previously described.
pupil behaviors
Time frame: through study completion, an average of 1 year
the pupil behaviors by Image J between first-eye and second-eye in bilateral cataract patients undergoing sequential FLACS
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 23 Aug 2022.
Related trials for Cataract
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
Aphakia, Postcataract
Not yet recruiting
Effects of Oxygen Cage Support During Cataract Surgery
Cataract
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments
Light Adjustable Lens, Objective Depth of Focus
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.
yu yinhui, MD principal investigator
Second Affiliated Hospital, Medical College of Zhejiang University, Hangzhou, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aqueous humor collection in people with Cataract, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 1 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 23 Aug 2022. 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?
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?
pain scores (time frame: through study completion, an average of 1 year). The study lists 3 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 23 Aug 2022.