Evaluating the Effect of Optical Zones on Correction for SMILE: Vector Analysis
1 other identifier
observational
140
1 country
1
Brief Summary
Evaluate the effect of the size of optical zones (OZ) on myopia and astigmatism correction in small incision lenticular extraction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2020
Shorter than P25 for all trials
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
August 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2021
CompletedFirst Submitted
Initial submission to the registry
August 11, 2021
CompletedFirst Posted
Study publicly available on registry
August 23, 2021
CompletedAugust 23, 2021
August 1, 2021
5 months
August 11, 2021
August 17, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
astigmatic changes
Observe the effect on changes in astigmatism by target induced astigmatism (TIA) versus surgically induced astigmatism (SIA)
2021.03
error value
Target refraction (TR) and surgically induced refraction (SIR) under different optical zones
2021.04
Study Arms (2)
group A
small optical zone
group B
large optical zone
Interventions
In patients with the same degree of myopia, different optical zones were designed for operation
Eligibility Criteria
age of patients between 18-45 years; spherical refraction of -3.00 to -6.00 diopters (D) with or without astigmatism (\<-3.00 D); spherical equivalent, -3.00 to -6.00 D; corrected distant visual acuity (CDVA), \>20/25
You may qualify if:
- no ocular conditions
- normal topography
- central corneal thickness, \>500µm
- residual stromal thickness, \>280 µm
- pupil diameter, 2.78-4.9 mm (average, 3.76±0.43 mm);
You may not qualify if:
- history of intraocular surgery
- pupil diameter, \>4.9 mm or \<2.78mm
- keratoconus or corneal ectasia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tianjin Eye Hospital
Tianjin, China
Related Publications (2)
Moshirfar M, Thomson AC, West WB Jr, Hall MN, McCabe SE, Thomson RJ, Ronquillo YC, Hoopes PC. Initial Single-Site Experience Using SMILE for the Treatment of Astigmatism in Myopic Eyes and Comparison of Astigmatic Outcomes with Existing Literature. Clin Ophthalmol. 2020 Oct 29;14:3551-3562. doi: 10.2147/OPTH.S276899. eCollection 2020.
PMID: 33154614RESULTDishler JG, Slade S, Seifert S, Schallhorn SC. Small-Incision Lenticule Extraction (SMILE) for the Correction of Myopia with Astigmatism: Outcomes of the United States Food and Drug Administration Premarket Approval Clinical Trial. Ophthalmology. 2020 Aug;127(8):1020-1034. doi: 10.1016/j.ophtha.2020.01.010. Epub 2020 Jan 15.
PMID: 32173114RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yan Wang
Tianjin Eye Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2021
First Posted
August 23, 2021
Study Start
August 1, 2020
Primary Completion
December 31, 2020
Study Completion
August 1, 2021
Last Updated
August 23, 2021
Record last verified: 2021-08