Evaluating the Effect of Optical Zones on Correction for SMILE: Vector Analysis

NCT ID: NCT05017376

Last Updated: 2021-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-01

Study Completion Date

2021-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Evaluate the effect of the size of optical zones (OZ) on myopia and astigmatism correction in small incision lenticular extraction.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

To retrospectively study whether different surgical optical zone sizes affect the correction of diopter and astigmatism in myopia patients. Divided into 2 groups according to the diameter of the optical zone. The vector analysis method was used to analyze the changes and errors of astigmatism in TR and SIR after operation. Generalized Estimation Equation (GEE) model is used for multiple regression analysis to evaluate the potential factors related to the error value.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Myopia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

group A

small optical zone

small incision lenticular extraction

Intervention Type PROCEDURE

In patients with the same degree of myopia, different optical zones were designed for operation

group B

large optical zone

small incision lenticular extraction

Intervention Type PROCEDURE

In patients with the same degree of myopia, different optical zones were designed for operation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

small incision lenticular extraction

In patients with the same degree of myopia, different optical zones were designed for operation

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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);

Exclusion Criteria

* history of intraocular surgery
* pupil diameter, \>4.9 mm or \<2.78mm
* keratoconus or corneal ectasia
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tianjin Eye Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yan Wang

Role: STUDY_CHAIR

Tianjin Eye Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Tianjin Eye Hospital

Tianjin, , China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 33154614 (View on PubMed)

Dishler 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.

Reference Type RESULT
PMID: 32173114 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TJYYLL-202034

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.