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Comparison of monocular implantation of the Acrysof Toric T2 intraocular lens with a standard monofocal intraocular lens in subjects with cataracts and low corneal astigmatism

Comparison of monocular implantation of the Acrysof Toric T2 intraocular lens with a standard monofocal intraocular lens in subjects with cataracts and low corneal astigmatism - Comparison Acrysof Toric T2 IOL with standard monofocal IOL

Status
Unknown
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON35670
Enrollment
10
Registered
2011-08-13
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

cataract

Interventions

All patients will undergo bilateral cataractsurgery
all surgery will be performed in the standard way by the same experienced surgeon. Patients will be their own control. In one eye the standard monofocal IOL will be implanted
model model Acrysof SNWF. In the other eye the toric T2 IOL will be implanted
model Acrysof Toric SN6AT2. The lenses have the same design, except for the minimal cylindrical correction on the posterior surface of the toric T2 IOL. The side of implantation of the toric T2 IOL

Sponsors

Isala Klinieken
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Bilateral age-related cataracts necessitating surger Preoperatieve regular corneal astigmatism of > 0,5 D and

Exclusion criteria

Exclusion criteria: Known ocular pathology which can affect the visus: corneal diseases, glaucoma, macula degeneration, (proliferative diabetic) retinopathy and neuro-opthalmic diseases. Previous corneal or intraocular surgery. History of macular edema, uveitis/iritis, retinal detachment or intraocular inflammation. Irregular astigmatism, pupil abnormalities, tear film abnormalities, iris abnormalities, extremely shallow anterior chamber, optic atrophy, microphthalmos, blind or absent follow eye, amblyopia. Pregnancy and lactation.;Pregnancy, lactation

Design outcomes

Primary

MeasureTime frame
Uncorrected distance visual acuity (UCDVA); pre- en postoperative for each eye

Secondary

MeasureTime frame
Best corrected visual acuity (BCDVA): pre- and postoperative for each eye Patient satisfaction with visual acuity for each eye questionnaire pre- and postoperative Manifest refraction (spherical and cylindrical) pre- and postoperative for each eye Axis of cylinder

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)