Clinical trial of the femtosecond laser VisuMax for refractive correction of hyperopia by the lenticule removal

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00004784

Enrollment

Registered

2013-04-02

Start date

2013-04-18

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

H52.0

Interventions

Group 1: Refractive correction of hyperopia with the femtosecond laser VisuMax

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: * The patient wishes the refractive correction of hyperopia * No previouse refractive surgery * Contact lens wearers must have removed the hard contact lenses at least 4 weeks and the soft contact lenses at least 2 weeks before the examination * Refractive errors: subjective hyperopia up to +6D, subjective astigmatism up to 5D, spherical equivalent (SEQ) up to +8D * Best corrected visual acuity 0.8 (in US notation 20/25) or better on both eyes

Exclusion criteria

Exclusion criteria: * Participation in other ophthalmic studies * Pregnant or nursing women, and women planning to become pregnant during the study * Existing corneal implants * Unstable refraction (over the last 2 years) * Immunocompromised patients (e.g. AIDS or autoimmune diseases) * Treatment with medications likely to affect wound healing such as steroids, antimetabolite or immunosuppressant * Diagnosis of connective tissue disease or diabetes * Any residual, recurrent or active disease of the eye (e.g. cataract; glaucoma suspect; corneal diseases; corneal thinning disorders such as keratoconus, pellucid marginal degeneration; dystrophy of basement membrane; exsudative macula degeneration; infections and inflammation of the eye) or of the cornea (e.g. corneal lesion or scarring; herpes simplex or herpes zoster keratitis) * Defective position of eyelid * Dry eye

Design outcomes

Primary

Measure	Time frame
To proof the safety and efficacy of the new lenticule removal method for the refractive correction of hyperopia the following parameters will be measured 1, 3, 6, and 9 months post-op: * uncorrected visual acuity (UCVA); * manifest refraction (sphere and cylinder); * best spectacle corrected visual acuity (BSCVA). Additionally, there will be a patient questionery with respect to the subjective feeling of side effects and patient satisfaction (preoperativelly, 1, 3, 6, and 9 months post-op).	—

Measure

Time frame

To proof the safety and efficacy of the new lenticule removal method for the refractive correction of hyperopia the following parameters will be measured 1, 3, 6, and 9 months post-op: * uncorrected visual acuity (UCVA); * manifest refraction (sphere and cylinder); * best spectacle corrected visual acuity (BSCVA). Additionally, there will be a patient questionery with respect to the subjective feeling of side effects and patient satisfaction (preoperativelly, 1, 3, 6, and 9 months post-op).

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Countries

Germany

Contacts

Public ContactMarcus Blum

HELIOS Klinikum Erfurt GmbH

marcus.blum@helios-kliniken.de(0361) 7812070

Outcome results

None listed

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