Senile CataractNCT03766230
Clinical Study on Second-eye Pain in Cataract Surgery
An observational study of Senile Cataract, run by Shanghai Eye Disease Prevention and Treatment Center.
Trial summary
The degree of perceived pain in the second-eye surgery of cataract patients is significantly higher than that in the first-eye surgery, which can lead to nervous tension during surgery and affect the surgical outcome and satisfaction. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Senile Cataract
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2018to 30 Oct 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Binocular senile cataract patients with binocular phacoemulsification and intraocular lens implantation to be performed at the Department of Ophthalmology in Shanghai Eye Disease Prevention and Treatment Center or Shanghai General Hospital from August 2018 to August 2020.
Who may be able to join
- diagnosed with binocular age-related cataract.
- Both eyes require phacoemulsification and intraocular lens implantation.
- binocular surgery was performed by the same physician in the same operating room, and the anesthesia and surgical procedures were consistent.
- Patients can fully understand the research purpose, research content, accidents and benefits and risks of the clinical trial, and can make their own decisions on participating or not.
Who cannot join
- -
About this study
Official title: Subclinical Sympathetic Response Related to Second-eye Pain in Cataract Surgery and Its Noninvasive Detection Index
The degree of perceived pain in the second-eye surgery of cataract patients is significantly higher than that in the first-eye surgery, which can lead to nervous tension during surgery and affect the surgical outcome and satisfaction. Study suggested that in addition to psychological factors, there might be subclinical sympathetic reactions leading to increased pain in the second-eyes, but the objective indicators and clinical relevance are not clear. Therefore, it is necessary to study the mechanism of second-eye pain in cataract surgery, and to provide a test index that can effectively predict the degree of intraoperative pain in patients, as an important reference for the development of a suitable time for second eye surgery.
This study is based on clinical case studies, recruiting patients with clinically diagnosed binocular age-related cataract and require binocular surgery, to compare the correlation of intraocular inflammatory factors in the second eye and patients' self-pain scores while both eyes' surgery are completed by the same doctor in the same operating room, and the correlation of the change of inflammatory factors and the time interval between the two eyes surgery, to analyze the second-eye subclinical sympathetic reaction changing with the time interval after the first cataract surgery from the molecular biological results. Using the latest international anterior segment vascularization optical coherence tomography(OCT) scan and optical microvascular imaging(OMAG) analysis technology to quantify iris blood flow, this study analyzes the iris blood flow density, vascular density and other indicators before and after cataract surgery, and carry out its correlation with the degree of intraocular subclinical sympathetic reaction, providing a rapid, non-invasive objective examination index of the second-eye subclinical sympathetic response.
Read the detailed description
- Coordination and Quality Control Team: The inspection and audit of this research project will be established mainly by hospital clinical research center staff and assisted by the Ophthalmology Reading Center team;
- The project team member will accept training before the study begins while unified inspection methods and requirements is established in standard operating procedures.
- The project team double enter the test data independently and establishes an electronic database.
- The project team randomly selects the data and repeats the measurements to ensure the accuracy as internal audit regularly.
- Conditions
- Senile Cataract
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 |
|---|---|---|
| peribulbar anesthesia1 | Time interval between two eyes' cataract surgery is or less than 14 days and using peribulbar anesthesia | |
| topical anesthesia1 | Time interval between two eyes' cataract surgery is or less than 14 days and using topical anesthesia | |
| peribulbar anesthesia2 | Time interval between two eyes' cataract surgery is from 15 to 21 days and using peribulbar anesthesia | |
| topical anesthesia2 | Time interval between two eyes' cataract surgery is from 15 to 21 days and using topical anesthesia | |
| peribulbar anesthesia3 | Time interval between two eyes' cataract surgery is from 22 to 28 days and using peribulbar anesthesia | |
| topical anesthesia3 | Time interval between two eyes' cataract surgery is from 22 to 28 days and using topical anesthesia | |
| peribulbar anesthesia4 | Time interval between two eyes' cataract surgery is from 29 to 60 days and using peribulbar anesthesia | |
| topical anesthesia4 | Time interval between two eyes' cataract surgery is from 29 to 60 days and using topical anesthesia | |
| peribulbar anesthesia5 | Time interval between two eyes' cataract surgery is from 61 to 90 days and using peribulbar anesthesia | |
| topical anesthesia5 | Time interval between two eyes' cataract surgery is from 61 to 90 days and using topical anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Surgery Pain Severity Score
visual analogue scale is used to assess the surgery pain. Visual analogue scales (VAS) are psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients. A VAS is usually a 100-mm long horizontal line with verbal descriptors (word anchors) at each end to express the extremes of the feeling, the position of the respondent's cross is generally assigned a score between 0 and 100.
Measured: Within one hour after first eye surgery; within one hour after second eye surgery (performed up to 90 days after first eye surgery)
Secondary outcomes (3)
Change in Concentration of inflammatory factors in aqueous humor
the Concentrations of tumor necrosis factor-α,interleukin-1,interleukin-6,interleukin-8,monocyte chemotactic protein-1,interleukin2,macrophage inflammatory protein-1α,macrophage inflammatory protein-1,carbon tetrachloride ,chemokine ligand 9,Tissue inhibitor of matrix metalloproteinase 01,C-C motif chemokine 11 are measured using Luminex
Measured: aqueous humor is acquired at the beginning of the first eye surgery and the second eye surgery (performed up to 90 days after first eye surgery)
Change in blood flow density of iris vascular
CIRRUS High Definition-OCT 5000(Carl Zeiss Meditec, Dublin, CA)
Measured: Within 24 hours before first eye surgery and Day 1, Week 1, Week 3, Month 1, Month 3 after first eye surgery, or within 24 hours before second-eye surgery (performed up to 90 days after first eye surgery)
Change in vascular density of iris vascular
CIRRUS High Definition-OCT 5000(Carl Zeiss Meditec, Dublin, CA)
Measured: Within 24 hours before first eye surgery and Day 1, Week 1, Week 3, Month 1, Month 3 after first eye surgery, or within 24 hours before second-eye surgery (performed up to 90 days after first eye surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start30 Dec 2018 (estimated)
- Primary completion30 Aug 2021 (estimated)
- Study completion30 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Senile CataractStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment Center
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03766230
- Sponsor's protocol ID
- YFZX2018006
- Status last verified
- Nov 2018
- First submitted
- 19 Aug 2018
- Last updated
- 6 Dec 2018
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subclinical Sympathetic Response Related to Second-eye Pain in Cataract Surgery and Its Noninvasive Detection Index
- ClinicalTrials.gov ID
- NCT03766230
- Acronym / sponsor ID
- YFZX2018006
- Conditions
- Senile Cataract
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment CenterUniversity, hospital or other
- Collaborators
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Study start
- 30 Dec 2018 (estimated)
- Primary completion
- 30 Aug 2021 (estimated)
- Study completion
- 30 Oct 2021 (estimated)
- First posted
- 6 Dec 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.
The degree of perceived pain in the second-eye surgery of cataract patients is significantly higher than that in the first-eye surgery, which can lead to nervous tension during surgery and affect the surgical outcome and satisfaction. Study suggested that in addition to psychological factors, there might be subclinical sympathetic reactions leading to increased pain in the second-eyes, but the objective indicators and clinical relevance are not clear. Therefore, it is necessary to study the mechanism of second-eye pain in cataract surgery, and to provide a test index that can effectively predict the degree of intraoperative pain in patients, as an important reference for the development of a suitable time for second eye surgery.
This study is based on clinical case studies, recruiting patients with clinically diagnosed binocular age-related cataract and require binocular surgery, to compare the correlation of intraocular inflammatory factors in the second eye and patients' self-pain scores while both eyes' surgery are completed by the same doctor in the same operating room, and the correlation of the change of inflammatory factors and the time interval between the two eyes surgery, to analyze the second-eye subclinical sympathetic reaction changing with the time interval after the first cataract surgery from the molecular biological results. Using the latest international anterior segment vascularization optical coherence tomography(OCT) scan and optical microvascular imaging(OMAG) analysis technology to quantify iris blood flow, this study analyzes the iris blood flow density, vascular density and other indicators before and after cataract surgery, and carry out its correlation with the degree of intraocular subclinical sympathetic reaction, providing a rapid, non-invasive objective examination index of the second-eye subclinical sympathetic response.
Detailed description
- Coordination and Quality Control Team: The inspection and audit of this research project will be established mainly by hospital clinical research center staff and assisted by the Ophthalmology Reading Center team;
- The project team member will accept training before the study begins while unified inspection methods and requirements is established in standard operating procedures.
- The project team double enter the test data independently and establishes an electronic database.
- The project team randomly selects the data and repeats the measurements to ensure the accuracy as internal audit regularly.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| peribulbar anesthesia1 | – | –Time interval between two eyes' cataract surgery is or less than 14 days and using peribulbar anesthesia |
| topical anesthesia1 | – | –Time interval between two eyes' cataract surgery is or less than 14 days and using topical anesthesia |
| peribulbar anesthesia2 | – | –Time interval between two eyes' cataract surgery is from 15 to 21 days and using peribulbar anesthesia |
| topical anesthesia2 | – | –Time interval between two eyes' cataract surgery is from 15 to 21 days and using topical anesthesia |
| peribulbar anesthesia3 | – | –Time interval between two eyes' cataract surgery is from 22 to 28 days and using peribulbar anesthesia |
| topical anesthesia3 | – | –Time interval between two eyes' cataract surgery is from 22 to 28 days and using topical anesthesia |
| peribulbar anesthesia4 | – | –Time interval between two eyes' cataract surgery is from 29 to 60 days and using peribulbar anesthesia |
| topical anesthesia4 | – | –Time interval between two eyes' cataract surgery is from 29 to 60 days and using topical anesthesia |
| peribulbar anesthesia5 | – | –Time interval between two eyes' cataract surgery is from 61 to 90 days and using peribulbar anesthesia |
| topical anesthesia5 | – | –Time interval between two eyes' cataract surgery is from 61 to 90 days and using topical anesthesia |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Binocular senile cataract patients with binocular phacoemulsification and intraocular lens implantation to be performed at the Department of Ophthalmology in Shanghai Eye Disease Prevention and Treatment Center or Shanghai General Hospital from August 2018 to August 2020.
Key inclusion criteria (4 listed)
- diagnosed with binocular age-related cataract.
- Both eyes require phacoemulsification and intraocular lens implantation.
- binocular surgery was performed by the same physician in the same operating room, and the anesthesia and surgical procedures were consistent.
- Patients can fully understand the research purpose, research content, accidents and benefits and risks of the clinical trial, and can make their own decisions on participating or not.
Key exclusion criteria (1 listed)
- -
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
Change in Surgery Pain Severity Score
Time frame: Within one hour after first eye surgery; within one hour after second eye surgery (performed up to 90 days after first eye surgery)
visual analogue scale is used to assess the surgery pain. Visual analogue scales (VAS) are psychometric measuring instruments designed to document the characteristics of disease-related symptom severity in individual patients. A VAS is usually a 100-mm long horizontal line with verbal descriptors (word anchors) at each end to express the extremes of the feeling, the position of the respondent's cross is generally assigned a score between 0 and 100.
3 secondary outcomes
Change in Concentration of inflammatory factors in aqueous humor
Time frame: aqueous humor is acquired at the beginning of the first eye surgery and the second eye surgery (performed up to 90 days after first eye surgery)
Change in blood flow density of iris vascular
Time frame: Within 24 hours before first eye surgery and Day 1, Week 1, Week 3, Month 1, Month 3 after first eye surgery, or within 24 hours before second-eye surgery (performed up to 90 days after first eye surgery)
Change in vascular density of iris vascular
Time frame: Within 24 hours before first eye surgery and Day 1, Week 1, Week 3, Month 1, Month 3 after first eye surgery, or within 24 hours before second-eye surgery (performed up to 90 days after first eye surgery)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Senile Cataract
Active, not recruitingPhase 2
A Multicenter, Randomized, Double-Masked, Placebo-Controlled Pilot Study to Evaluate the Efficacy and Safety of ZOC2017217 in Subjects With Age-Related Cataract
Age Related Cataracts
Active, not recruitingObservational study
Multicenter Study on the Use of Intraoperative OCT in the Diagnosis and Management of Lens Diseases
Lens Diseases, Cataract
Active, not recruiting
A Clinical Feasibility Study of the Aquea Intracanalicular Glaucoma Micro-coil Stent
Glaucoma, Open-Angle, Cataract Senile
RecruitingObservational study
Small RNA tRF-31 Changes in Patients With Age-Related Cataract
Cataract
RecruitingObservational study
The Impact of Surgical Procedures on Postoperative Outcomes in Cataract Phacoemulsification and Analysis of Related Factors
Age-related Cataract
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Senile Cataract, run by Shanghai Eye Disease Prevention and Treatment Center.
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 6 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in Surgery Pain Severity Score (time frame: Within one hour after first eye surgery; within one hour after second eye surgery (performed up to 90 days after first eye surgery)). 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 6 Dec 2018.