Association Between ORA and Residual Refractive Astigmatism After SMILE

• Sponsor: Taipei Nobel Eye Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT05604872
• Collaborator: (none)
• Enrollment: 530
• Location: 1
• Actual Duration (Months): 24.9
• Patients Per Site Per Month: 21.3

Study Details

Study Description

Brief Summary

The aim of our study is to analysis and compare the relationship between ORA and postoperative astigmatism in low astigmatism (less than 1D) and moderate to high (1D to 3D) astigmatism patients after SMILE (Small Incision Lenticule Extraction) refractive surgery.

Condition or Disease	Intervention/Treatment	Phase
Refractive Errors; Astigmatism	Procedure: Small Incision Lenticule Extraction

Study Design

• Study Type: Observational
• Actual Enrollment: 530 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Association Between Preoperative Ocular Residual Astigmatism(ORA) and Residual Refractive Astigmatism After SMILE Refractive Surgery
• Actual Study Start Date: Jun 1, 2020
• Actual Primary Completion Date: Jun 30, 2022
• Actual Study Completion Date: Jun 30, 2022

Outcome Measures

Primary Outcome Measures

1. Corrected distance visual acuity [3 months after surgery]

   in LogMAR unit

2. Manifest refraction [3 months after surgery]

   in Diopter

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Corrected distance visual acuity of both eyes reaches 0.1 logarithm of the minimum angle of resolution (logMAR)

• Stable refractive errors of myopia and astigmatism who received SMILE refractive surgery of both eyes

Exclusion Criteria:

• Cataract

• Corneal opacities or irregularities

• Dry eye (Schirmer's test I ≤ 5mm)

• Amblyopia

• Coexisting ocular pathologies

• Glaucoma

• Non-dilating pupil

• History of intraocular surgery, laser therapy, or retinopathy

• Optic nerve or macular diseases

• Estimated postoperative cornea residual stromal thickness less than 250 μm

• Pregnancy or under lactation

• Uncontrolled diabetic mellitus or systemic immune disease _Refusal or unable to maintain follow-up

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Taipei Nobel Eye Clinic	Taipei		Taiwan

Sponsors and Collaborators

• Taipei Nobel Eye Clinic

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chao-Kai Chang, Dean, Taipei Nobel Eye Clinic
• ClinicalTrials.gov Identifier: NCT05604872
• Other Study ID Numbers: 003
• First Posted: Nov 3, 2022
• Last Update Posted: Nov 3, 2022
• Last Verified: Oct 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Astigmatism; Refractive Errors

Study Results

No Results Posted as of Nov 3, 2022