Clinical Study on Second-eye Pain in Cataract Surgery

NCT03766230 | Unknown

• 1 other identifier: YFZX2018006
• Study Type: observational
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Senile Cataract

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  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)

Study Arms (10)

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

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Eye Disease Prevention and Treatment Center: lead
• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

The aqueous humor will be obtained in the surgery and kept in centrifugal tube. The amount of inflammatory cytokines will be measured afterwards.

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2018
• First Posted: December 6, 2018
• Study Start: December 30, 2018
• Primary Completion: August 30, 2021
• Study Completion: October 30, 2021
• Last Updated: December 6, 2018

Record last verified: 2018-11