Optimal keratoplasty for the correction of presbyopia and hypermetropia

In patients with presbyopia and hypermetropia, do optimal keratoplasty improve near and distance visual acuity?

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN22899379

Enrollment

Registered

2017-03-14

Start date

2014-07-01

Completion date

Unknown

Last updated

2022-03-01

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

Conditions

Presbyopia and hypermetropia Eye Diseases Presbyopia and hypermetropia

Interventions

All patients undergo laser irradiation of the corneal tissue using the NTK Optimal Keratoplasty (Opti-K) System. While the patient is lying in a supine position, an output beam is dir

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 40 years and over 2. Low to moderate hypermetropia (manifest refraction: sphere between +1 to +2.5 D, absolute cylinder =1 D) or presbyopia (with presbyopic adds between +1D to +2.75 D) 3. Documented stable refraction 4. Corrected distance visual acuity (CDVA) of 33 Early Treatment Diabetic Retinopathy Study (ETDRS) letters or better

Exclusion criteria

Exclusion criteria: 1. Nystagmus 2. Corneal diameter =9 mm 3. Central corneal thickness =500 µm 4. Dry eye disease 5. Severe blepharitis 6. Residual, recurrent or active corneal disease or abnormality

Design outcomes

Primary

Measure	Time frame
Mean uncorrected near visual acuity is measured by ETDRS charts and standardized procedures at baseline and 6 months.	—

Secondary

Measure	Time frame
Uncorrected distance visual acuity in hypemetropic/presbyopic eyes is measured by ETDRS charts and standardized procedures at baseline and 6 months.	—

Countries

Italy

Contacts

Public ContactPaolo Lanzetta

Outcome results

None listed

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