A Randomized Controlled Study of Phacoemulsification by the Enlarged Internal Incision and the Regular 2.2mm Incision
NCT ID: NCT03976791
Last Updated: 2019-06-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
294 participants
INTERVENTIONAL
2019-07-01
2019-12-30
Brief Summary
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The aim of this study: To evaluate whether the technique of enlarging internal incision could reduce the incidence of descemet membrane detachment after 2.2 mm incision phacoemulsification.
Secondary outcome: To evaluate whether the technique of enlarged internal incision can reduce other corneal complications such as corneal edema and astigmatism after 2.2 mm incision phacoemulsification.
Study Design: A prospective randomized controlled study
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Enlarged internal incision
enlarged the internal incision about 0.4mm
enlarged internal incision
enlarging the internal incision about 0.4mm
Regular 2.2mm incision
regular 2.2mm corneal incision for microincision coaxial phacoemulsification
regular 2.2mm incision
2.2mm microincision coaxial phacoemulsification
Interventions
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enlarged internal incision
enlarging the internal incision about 0.4mm
regular 2.2mm incision
2.2mm microincision coaxial phacoemulsification
Eligibility Criteria
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Inclusion Criteria
* Age from 65 to 90
* The diameter of pupil after mydriasis is more than 6 mm
* LOCS III nuclear grade ≥4
* Corneal endothelial cell count \> 1500 cells/mm2
* Phacoemulsification and intraocular lens implantation are planned
* Agree to participate in this study and sign informed consent
Exclusion Criteria
* Anterior segment lesions (exfoliation syndrome, suspension ligament injury or relaxation, corneal and iris lesions, glaucoma)
* Other ocular diseases that impair visual function, such as optic neuropathy, uveitis and ocular tumors
* History of Ophthalmic Surgery
* Intraoperative and Postoperative Complications
65 Years
90 Years
ALL
Yes
Sponsors
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Zhongshan Ophthalmic Center, Sun Yat-sen University
OTHER
Responsible Party
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Principal Investigators
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Yizhi Liu, Doctor
Role: PRINCIPAL_INVESTIGATOR
Zhongshan Ophthalmic Center, Sun Yat-sen University
Locations
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Zhongshan Ophthalmic Center
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Yizhi Liu, Doctor
Role: primary
Other Identifiers
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2019KYPJ078
Identifier Type: -
Identifier Source: org_study_id
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