An interventional study of OptiVis, Aaren Scientific and Monofocal IOL in Cataract Senile and Lenses, Intraocular, sponsored by Parc de Salut Mar. Completed. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-05-01.
Sponsored by Parc de Salut Mar · Not applicable, Interventional, and Treatment
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.
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) .
1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.
This study's enrollment of 32 is below the median of 80 across 1,155 interventional studies indexed under Cataract.
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Exclusion Criteria:
Ambulatory surgery was performed by the same, experienced surgeon, under topical anesthesia, using as a technique phacoemulsification with small incision (2.75) in clear cornea in the most curved meridian. The randomly assigned IOL (in this arm: a hybrid (refractive-diffractive) multifocal IOL (OptiVis, Aaren Scientific) was implanted in the capsular bag. The second eye with the same type of lens of the first eye was operated within 2-4 weeks.
Device: OptiVis, Aaren Scientific
Ambulatory surgery was performed by the same, experienced surgeon, under topical anesthesia, using as a technique phacoemulsification with small incision (2.75) in clear cornea in the most curved meridian. The randomly assigned IOL (in this arm: a monofocal IOL (AR40e, AMO) was implanted in the capsular bag. The second eye with the same type of lens of the first eye was operated within 2-4 weeks.
Device: Monofocal 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).
Also known as: a hybrid multifocal intraocular lens
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).
Also known as: AR40e, AMO-Abbot 30 Laboratories Inc.
Visual function
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.
Time frame: The last follow-up visit (3 months after the surgery)
Contrast sensitivity (CS)
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)
Time frame: The last follow-up visit (3 months after the surgery)
Refractive Outcomes
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).
Time frame: The last follow-up visit (3 months after the surgery)
Spectacle dependence
Spectacle dependence, determined by questionnaire (Do you wear glasses for distance/near vision?).
Time frame: The last follow-up visit (3 months after the surgery)
Presence of dysphotopsia
Presence of dysphotopsia (halos, glare), spontaneously mentioned or elicited in response to questioning were determined by questionnaire.
Time frame: The last follow-up visit (3 months after the surgery)
Patient satisfaction
Patient satisfaction was also assessed with the VF-14 test, consisting of 14 questions evaluating various patient activities.
Time frame: The last follow-up visit (3 months after the surgery)
No study locations are listed for this record.
Plan to share: Yes — All IPD that underlie results in a publication
Supporting information: Study protocol, Sap, Icf
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Parc de Salut Mar