An observational study in Senile Cataract, sponsored by Shanghai Eye Disease Prevention and Treatment Center. Status unknown. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-12-06.
Sponsored by Shanghai Eye Disease Prevention and Treatment Center · Observational
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.
1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.
This study's planned enrollment of 600 is above the median of 81 across 484 observational studies indexed under Cataract.
Browse Cataract studies →Shanghai Eye Disease Prevention and Treatment Center is the lead sponsor of 64 studies on the registry; 30 are open to participants now.
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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.
Exclusion Criteria:
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Time interval between two eyes' cataract surgery is or less than 14 days and using peribulbar anesthesia
Time interval between two eyes' cataract surgery is or less than 14 days and using topical anesthesia
Time interval between two eyes' cataract surgery is from 15 to 21 days and using peribulbar anesthesia
Time interval between two eyes' cataract surgery is from 15 to 21 days and using topical anesthesia
Time interval between two eyes' cataract surgery is from 22 to 28 days and using peribulbar anesthesia
Time interval between two eyes' cataract surgery is from 22 to 28 days and using topical anesthesia
Time interval between two eyes' cataract surgery is from 29 to 60 days and using peribulbar anesthesia
Time interval between two eyes' cataract surgery is from 29 to 60 days and using topical anesthesia
Time interval between two eyes' cataract surgery is from 61 to 90 days and using peribulbar anesthesia
Time interval between two eyes' cataract surgery is from 61 to 90 days and using topical anesthesia
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.
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)
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
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
CIRRUS High Definition-OCT 5000(Carl Zeiss Meditec, Dublin, CA)
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
CIRRUS High Definition-OCT 5000(Carl Zeiss Meditec, Dublin, CA)
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)
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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Shanghai Eye Disease Prevention and Treatment Center