Cataract Senile, Lenses, Intraocular
Conditions
Keywords
OptiVis, hybrid multifocal intraocular lens, multifocal intraocular lens, presbyopia
Brief summary
This study evaluated visual outcome after cataract surgery with bilateral implantation of either a diffractive - refractive (hybrid) multifocal intraocular lens (MFIOL) or monofocal intraocular lens (IOL) as a control grup.
Detailed description
PURPOSE: To present the outcomes of hybrid multifocal and monofocal intraocular lenses (IOL) SETTING: Parc de Salut Mar, Universidad Pompeu-Fabra - Autónoma, Barcelona, Spain. DESIGN: Prospective clinical trial. METHODS: Consecutive patients with bilateral cataract were included. Phacoemulsification with randomized implantation of either a monofocal IOL (AR40e, AMO-Abbot 30 Laboratories Inc. Abbot Park, Illinois, USA) or multifocal IOL (OptiVis™, Aaren Scientific, Inc, Ontario, CA, USA) was performed by the same surgeon and under the same conditions. Over a 3-month follow-up, the main outcome measures were uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), uncorrected intermediate visual acuity at 60 cm (UIVA), distance-corrected intermediate visual acuity (DCIVA), uncorrected near visual acuity at 33 cm (UNVA), distance-corrected near visual acuity (DCNVA), spherical equivalent (SE), contrast sensitivity (CS), presence of dysphotopsia, use of spectacles and patient satisfaction with the test VF-14 (Visual Function Index) .
Interventions
DEVICEOptiVis, Aaren Scientific
All the surgeries were performed under topical anesthesia using a standard phacoemulsification procedure with Infiniti Vision System (all from Alcon Laboratories, Inc, Fort Worth, TX).
DEVICEMonofocal IOL
All the surgeries were performed under topical anesthesia using a standard phacoemulsification procedure with Infiniti Vision System (all from Alcon Laboratories, Inc, Fort Worth, TX).
Sponsors
Parc de Salut Mar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Consecutive patients with bilateral cataract were included after meeting all the inclusion and none of exclusion criteria and when written informed consent was obtained from all patients. Patients were randomly assigned to have bilateral implantation with either a monofocal IOL (AR40e, AMO-Abbot 30 Laboratories Inc. Abbot Park, Illinois, USA) or multifocal IOL (OptiVis™, Aaren Scientific, Inc, Ontario, CA, USA).
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* senile cataract with Snellen visual acuity ≤ 0.5, * motivation for spectacle independence for near vision (as the study was conducted in Spanish public health care system, entering study was the only option to get multifocal lens, as they are not provided by public health care, and the patients were conscious of the possibility of randomization to monofocal group.)
Exclusion criteria
* corneal astigmatism ≥ 1.10 diopters (D) and irregular astigmatism, * axial length \< 21.5 or ≥ 25 mm, * pupillary diameter in mesopic conditions in distance vision ≤ 2.5 mm and ≥ 6 mm, * ocular pathology that could affect the visual function and/or intraocular lens centering and intraoperative or postoperative complications. * highly demanding patients and those whose profession could be affected by a multifocal design (professional drivers, jewelers etc.) were also excluded (as in the Spanish public health care system secondary procedures needed to satisfy patients' expectation, such as LRI´s, LASIK, PRK´s, are not available).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual function | The last follow-up visit (3 months after the surgery) | Changes in visual acuity in logMAR: uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA) at 6 m, uncorrected intermediate visual acuity (UIVA), distance-corrected intermediate visual acuity (DCIVA) at 60 cm (in the OptiVis group only, as they were supposed to provide intermediate distance vision in contrary to monofocal lenses), uncorrected near visual acuity (UNVA) and distance-corrected near visual acuity (DCNVA) at 33 cm. All measured using Snellen acuity charts under photopic conditions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Contrast sensitivity (CS) | The last follow-up visit (3 months after the surgery) | Changes in monocular and binocular CS were measured in mesopic conditions, without glare at spatial frequencies of 1.5, 3, 6, 12 and 18 cycles per degree (cpd) using the Functional Acuity Contrast Test (FACT, OPTEC 6500®, Stereo Optical Co. Inc) |
| Refractive Outcomes | The last follow-up visit (3 months after the surgery) | The predictability of the refractive outcome. Postoperative spherical equivalent (SE) and SE within ±0.50 D of the attempted spherical correction (emmetropy) and within ±1.00 D of the attempted spherical correction (emmetropy). |
| Spectacle dependence | The last follow-up visit (3 months after the surgery) | Spectacle dependence, determined by questionnaire (Do you wear glasses for distance/near vision?). |
| Presence of dysphotopsia | The last follow-up visit (3 months after the surgery) | Presence of dysphotopsia (halos, glare), spontaneously mentioned or elicited in response to questioning were determined by questionnaire. |
| Patient satisfaction | The last follow-up visit (3 months after the surgery) | Patient satisfaction was also assessed with the VF-14 test, consisting of 14 questions evaluating various patient activities. |
Outcome results
None listed