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Clinical study on the effect of accommodative training in preventing and alleviating asthenopia after SMILE in pre-presbyopic myopic patients

Clinical study on the effect of accommodative training in preventing and alleviating asthenopia after SMILE in pre-presbyopic myopic patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500115179
Enrollment
Unknown
Registered
2025-12-23
Start date
2025-12-31
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Visual fatigue

Interventions

Trail Group 2:Flipper training
Control Group:None
Trail Group 1:Virtual reality (VR) training

Sponsors

Zhongshan Ophthalmic Center,Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 35-45 who underwent SMILE surgery in both eyes, with the dominant eye selected as the primary study eye; 2. Both eyes meet the SMILE surgery criteria before surgery; 3. Preoperative accommodation amplitude of 3.5D-7D; 4. Preoperative astigmatism = 0.8; 6. Experiencing visual fatigue 1 week after surgery. Diagnostic criteria for visual fatigue: (1) blurred vision, inability to maintain prolonged focus, difficulty in focusing, inaccurate focusing; (2) ocular discomfort such as eye fatigue, eye soreness, eye pain, pulling sensation in the eyeball, photophobia, tearing, foreign body sensation, or dryness; (3) accompanied by headache, lack of concentration, easy fatigue, or memory decline. Diagnosis can be made if 2 of (1), (2), and (3) are present; 7. Accommodative sensitivity <11 cpm/min in one eye, <8 cpm/min in both eyes one week after surgery; 8. Agree to perform 15 minutes of VR training/reverse photography training at home daily during the study period, notify the researchers if unable to comply, and are able to accept and complete follow-up examinations on time; 9. I understand and agree to participate in this clinical trial and have signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Have absolute contraindications for SMILE surgery. 2. Have SMILE surgery failure/abnormalities. 3. Have received flipper/other visual function training within the past half year. 4. Have used anti-fatigue drugs within one month prior to enrollment. 5. Have active eye diseases. 6. Have severe dry eyes. 7. Have eye diseases such as glaucoma, strabismus, amblyopia, and nystagmus. 8. Have a history of eye trauma or other eye surgeries. 9. Have other systemic diseases that affect eye health (such as mental illness). 10. Participants who are simultaneously involved in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Change in accommodative facility;

Secondary

MeasureTime frame
Changes in positive and negative relative accommodation (PRA/NRA) and amplitude of accommodation (AA);Changes in asthenopia scores;Changes in spherical equivalent (SE), uncorrected near visual acuity (UNVA), uncorrected distance visual acuity (UDVA), and best-corrected distance visual acuity (CDVA);

Countries

China

Contacts

Public ContactLei Lei

Zhongshan Ophthalmic Center,Sun Yat-sen University

15989137069@163.com+86 20 1234 5678

Outcome results

None listed

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