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Impact of One-Step EVO-ICL Surgery on Tear Function and Visual Quality: A Study on Efficacy and Safety

Impact of One-Step EVO-ICL Surgery on Tear Function and Visual Quality: A Study on Efficacy and Safety - Evaluation of the Efficacy and Safety of the One-Step EVO-ICL Surgery

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600116198
Enrollment
Unknown
Registered
2026-01-06
Start date
2025-07-01
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Ametropia

Interventions

experimental group:Adopting the improved one-step EVO-ICL implantation technique
Control Group One:Using the min-ophthalmic viscosurgical device technique
Control Group Two:Using one-step technique

Sponsors

Xi'an People's Hospital (Xi'an Fourth Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18 - 45 years old; 2. For patients wearing contact lenses, it is recommended to stop wearing them before the surgery. Generally, soft lenses should be discontinued for 1 week, rigid gas-permeable contact lenses for 3 weeks, and orthokeratology lenses for 3 months; 3. No eye diseases, trauma or surgical history; 4. No family history, especially no history of corneal dystrophy or glaucoma; 5. No history of systemic diseases; 6. No history of medication, adverse drug reactions or allergies; 7. The patient has the desire to improve refractive status through posterior chamber intraocular lens implantation of the crystalline lens and has reasonable expectations for the surgical outcome; 8. For patients with myopia or combined astigmatism, it is generally required that the refractive power remain relatively stable, that is, the annual change in refractive power should be = 2000 cells/mm2, with stable cell morphology; 10. Anterior chamber depth >= 2.80 mm and the angle is open; 11. There are no other obvious eye diseases and/or systemic organic lesions that affect vision and/or the recovery after surgery.

Exclusion criteria

Exclusion criteria: The presence of any one of the following conditions: 1. Unstable keratoconus or other keratectatic changes; 2. Corneal endothelial dystrophy; 3. Active eye disease or infection; 4. Severe ocular adnexal diseases, such as eyelid defect, deformity and severe eyelid dysraphism; 5. Previous glaucoma, cataract, uveitis and other eye diseases that significantly affect vision; 6. Severe anxiety, depression and other psychological and mental diseases; 7. Diseases that cannot cooperate with examination and surgery, such as epilepsy, hysteria, etc. 8. Severe hyperthyroidism with exophthalmos and the condition is not stable.

Design outcomes

Primary

MeasureTime frame
Time of operation;Uncorrected visual acuity, the best corrected visual acuity, and the intraocular pressure;Inflammatory response, anterior chamber cells;Corneal endothelial parameters;Anterior chamber depth, vault height;Visual Quality Questionnaire Survey;

Secondary

MeasureTime frame
Gender, age, spherical and cylindrical lens power;

Countries

China

Contacts

Public ContactLin Guo

Xi'an People's Hospital (Xi'an Fourth Hospital)

g-lin@126.com+86 186 2903 6361

Outcome results

None listed

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