A Randomized Controlled Study of Phacoemulsification by the Enlarged Internal Incision and the Regular 2.2mm Incision
1 other identifier
interventional
294
1 country
1
Brief Summary
Objective and Principle: To evaluate whether enlarging the incision can reduce corneal complications associated with phacoemulsification with regular 2.2 mm incision. 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2019
CompletedFirst Posted
Study publicly available on registry
June 6, 2019
CompletedStudy Start
First participant enrolled
July 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2019
CompletedJune 14, 2019
June 1, 2019
4 months
June 4, 2019
June 11, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
descemet membrane detachment(DMD)
DMD at the incision observed by anterior segment optical coherence tomography
postoperative 1 week
Study Arms (2)
Enlarged internal incision
EXPERIMENTALenlarged the internal incision about 0.4mm
Regular 2.2mm incision
PLACEBO COMPARATORregular 2.2mm corneal incision for microincision coaxial phacoemulsification
Interventions
enlarging the internal incision about 0.4mm
2.2mm microincision coaxial phacoemulsification
Eligibility Criteria
You may qualify if:
- Age-related cataract patients
- 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
You may not qualify if:
- History of ocular trauma
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zhongshan Ophthalmic Center
Guangzhou, Guangdong, 510060, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yizhi Liu, Doctor
Zhongshan Ophthalmic Center, Sun Yat-sen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2019
First Posted
June 6, 2019
Study Start
July 1, 2019
Primary Completion
November 1, 2019
Study Completion
December 30, 2019
Last Updated
June 14, 2019
Record last verified: 2019-06