Factor Analysis of Unintended Initial Dissection of the Posterior Plane

NCT05367154 | Completed DMC

• 1 other identifier: [2021] No. (031)
• Study Type: observational
• Target: 3,003
• Locations: 1 country
• Sites: 1

Brief Summary

To explore the potential factors for unintended initial dissection of the posterior plane in a large sample retrospective analysis and surgeons of different levels.

Conditions

Myopia; Small-incision Lenticule Extraction (SMILE) Surgery

Keywords

femtosecond laser; small-incision lenticule extraction (SMILE); unintended initial dissection of the posterior plane

Outcome Measures

Primary Outcomes (1)

• The number of patients with unintended initial dissection of the posterior plane in the SMILE surgeries

  The number of patients with unintended initial dissection of the posterior plane were observed during the SMILE surgeries.

  Day 0

Secondary Outcomes (5)

• The impact of spherical equivalent on the unintended initial dissection of the posterior plane (UIDPP) in SMILE surgeries

  Day 0

• The impact of peripheral corneal incision angle on the unintended initial dissection of the posterior plane (UIDPP) in SMILE surgeries

  Day 0

• The impact of peripheral lens thickness on the unintended initial dissection

  Day 0

• The impact of lens diameter on the unintended initial dissection

  Day 0

• The impact of central corneal thickness on the unintended initial dissection

  Day 0

Study Arms (1)

Eyes with SMILE surgeries

Eyes with SMILE surgeries which were performed by three surgeons with different experiences.

Procedure: Small incision lenticule extraction

Interventions

Small incision lenticule extraction PROCEDURE

Small incision lenticule extraction surgeries performed by two Refractive surgery experts (Refractive surgery expert 1: YYF, Associate Professor with 10 years of experience as a refractive surgeon; Refractive surgery expert 2: GF, Associate Professor with 5 years of experience as a refractive surgeon) and a Attending ophthalmologist (WNY, Attending ophthalmologist with 1 year of experience as a refractive surgeon).

Eyes with SMILE surgeries

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients from clinics in ophthalmic center of the second Affiliated Hospital of Nanchang University

You may qualify if:

• A condition in which the spherical equivalent refractive error of an eye is ≤ -0.50 D when ocular accommodation is relaxed;
• Age ≥18 years;
• Spherical equivalent (SE) ≥ -10.0D;
• Corrected distance visual acuity (CDVA) ≥ 16/20;
• Stable myopia for at least 2 years;
• No contact lenses wearing for at least 2 weeks.

You may not qualify if:

• The presence or history of eye conditions other than myopia and astigmatism, such as keratoconus or external eye injury;
• A history of eye surgery;
• The presence or history of systemic diseases.

Sponsors & Collaborators

• Yifeng Yu: lead

Study Sites (1)

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330000, China

Location

MeSH Terms

Conditions

Myopia; Smiling

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases; Facial Expression; Nonverbal Communication; Communication; Behavior

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy chief physician of Ophthalmology center of the Second Affiliated Hospital of Nanchang University

Study Record Dates

• First Submitted: April 29, 2022
• First Posted: May 10, 2022
• Study Start: April 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: May 10, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)