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Clinical study of Presbyopic Correction Using Monocular Bi-aspheric Ablation Profile (PresbyMAX)

Clinical study of Presbyopic Correction Using Monocular Bi-aspheric Ablation Profile (PresbyMAX)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONC-17012407
Enrollment
Unknown
Registered
2017-08-18
Start date
2017-08-21
Completion date
Unknown
Last updated
2017-08-21

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

Conditions

refractive error Presbyopic

Interventions

2:Mel 90 laser treatment

Sponsors

Eye and ENT Hospital of Fudan University, Myopia Key Laboratory of the Health Ministry
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. Be at least 35 years of age, male or female, of any race; 2. Provide written informed consent; 3. Willingness and ability to follow all instructions and comply with schedule for follow-up visits; 4. Diagnosed as refractive error with Presbyopic; 5. Contact Lens Wearers Only: Removal of contact lenses for the required period of time prior to the screening refraction: Contact Lens Type Minimum Discontinuation TimeSoft 1 WeekSoft Extended Wear 1 WeekSoft Toric 2 Weeks Rigid gas permeable 2 Weeks.

Exclusion criteria

Exclusion criteria: 1. current use of any medication due to a psychiatric disorder or cognitive impairment that might affect the psychological assessment; 2. subjects who had undergone ocular surgery within the last 6 months; 3. Pregnancy (including plans to become pregnant) or lactation during the course of the study; 4. Patients with nystagmus or any other condition that would prevent a steady gaze during the treatment or other diagnostic tests.

Design outcomes

Primary

MeasureTime frame
Vision Acuity;Refraction;Vision Quality;Corneal tomography;OCT observation;

Countries

China

Contacts

Public ContactXingtao Zhou

Eye and ENT Hospital of Fudan University, Myopia Key Laboratory of the Health Ministry

doctzhouxingtao@163.com+86 021-64377134

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026