Clinical study of excimer laser micro-monocular multi-focal double aspherical ablation mode for myopia and presbyopia correction

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300074821

Enrollment

Unknown

Registered

2023-08-17

Start date

2021-03-01

Completion date

Unknown

Last updated

2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

presbyopia

Interventions

Myopia and presbyopia group:Aberration-Free anamorphic ablation was selected as the dominant eye to completely correct ametropia. PresbyMAX monocular ablation mode was used in non-dominant eyes.

Eligibility

Sex/Gender

All

Age

40 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1.aged from 40 to 55 years old, was diagnosed as presbyopia with both eyes. 2.spherical equivalent -1.00D~-8.00D; Astigmatism =4.00D. 3.ADD +1.25~+2.50D. 4.monocular BCDVA= 0.8,monocular BCNVA= J2. 5.Monocular vision test can tolerate anisometropia for at least 1 D. 6.The diameter of bright pupil 2.5~3.5mm, the diameter of dark pupil > 4.5 mm. 7.Corneal spherical aberration @ 6mm > 0.0µ m, root mean square value (RMS) of corneal higher-order aberration @ 6mm < 0.5µm. 8.Preoperative :anterior corneal curvature 40.0~48.0D.postoperative:anterior corneal curvature 35.0 ~ 48.0d . 9.Meet the indications for LASIK as listed in the Chinese Expert Consensus on Clinical diagnosis and treatment in Laser Corneal Refractive Surgeries.

Exclusion criteria

Exclusion criteria: 1.Current active inflammation or infection of the eye. 2.Those with abnormal preoperative corneal topography and biomechanical examination. Expected post-cutting corneal stromal thickness <300um and preoperative central corneal thickness <470um 3.Pupil offset= 0.7mm. 4.intolerance to micro-monovision testing with contact lenses or trial frame for at least 1 D. 5.Have an eye condition that affects vision other than refractive error,history of ocular surgery (including laser refractive surgery) and traumatism . 6.Anxiety, depression and Those who have high demands for postoperative visual quality and vision.

Design outcomes

Primary

Measure	Time frame
UDVA,UIVA,UNVA;BCVA,BIVA,BNVA;Corneal morphological index;Defocusing curve;4th and 6th order corneal spherical aberrations;	—

Secondary

Measure	Time frame
Dioptric;the 25-item National Eye Institute Visual Function Quest ionnaire;Q Value of Corneal Anterior Surface;Overall corneal wavefront aberration;Higher-order corneal aberrations;	—

Countries

China

Contacts

Public ContactJipeng

Affiliated Eye Hospital of Shandong University of Traditional Chinese Medicine

ji6605@126.com+86 135 7375 3812

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 27, 2026