Combined Vitrectomy and Femtosecond Laser-assisted Cataract Surgery
Clinical Assessment of Combined Vitrectomy and Femtosecond Laser-assisted Cataract Surgery
1 other identifier
interventional
100
1 country
1
Brief Summary
Based on the progress of cataract surgery, intraocular lens development, vitreoretinal surgery and anesthesia technology in recent years, the purpose of this study is to develop a new type of more accurate and minimally invasive combined surgery for cataract and fundus diseases, and to evaluate the advantages and value of the surgery as well as related complications, so as to minimize the surgical trauma and obtain faster visual function recovery and better patient comfort. To provide new solutions for the growing demand of eye health care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2017
Longer than P75 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
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
December 8, 2020
CompletedFirst Posted
Study publicly available on registry
October 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedOctober 20, 2022
October 1, 2022
7 years
December 8, 2020
October 17, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
visual acuity
final best-corrected visual acuity
Change from baseline best-corrected visual acuity at 6 months.
Secondary Outcomes (1)
complications
through study completion, an average of 6 months.
Study Arms (4)
RRD group
EXPERIMENTALto evaluate the efficacy and complications of a new minimally invasive vitreoretinal surgery combined with FLACS in the treatment of rhegmatogenous retinal detachment complicated with cataract.
ERM group
EXPERIMENTALto evaluate the efficacy and complications of a new minimally invasive vitreoretinal surgery combined with FLACS in the treatment of epiretinal membrane complicated with cataract.
MH group
EXPERIMENTALto evaluate the efficacy and complications of a new minimally invasive vitreoretinal surgery combined with FLACS in the treatment of macular hole complicated with cataract.
Vitreous cloudy group
EXPERIMENTALto evaluate the efficacy and complications of a new minimally invasive vitreoretinal surgery combined with FLACS in the treatment of vitreous opacity complicated with cataract.
Interventions
The procedures are combined the FLACS +PPV+IOL + epiretinal membrane peeling + Ozurdex.
The procedures are combined the FLACS + PPV+IOL + internal limiting membrane peeling + air.
Eligibility Criteria
You may qualify if:
- RRD with cataract
- ERM with cataract
- MH with cataract
- Vitreous opacity with cataract
You may not qualify if:
- intraocular surgery
- ocular trauma
- endophthalmitis
- uveitis
- glaucoma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jiasong Yang
Shanghai, 200000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Wensheng Li
Aier Ophthalmology School of Central South University; Shanghai Aier Eye Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2020
First Posted
October 20, 2022
Study Start
January 1, 2017
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
October 20, 2022
Record last verified: 2022-10