Low Add Multifocal Versus Extended Depth of Focus Intraocular Lens

NCT04865016 | Completed

• 1 other identifier: 09.2016.309
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

The innovations in phacoemulsification surgery and advances in surgical equipment ensure a safe extraction of the crystalline lens and implantation of intraocular lenses (IOL). As a result of developing intraocular lens technologies and changing patient demands, many multifocal, accommodative, toric, toric-multifocal, and extended depth of focus (EDOF) IOLs have been introduced and the original aim of restoration of far vision with implanted monocular IOLs has been evolved to an objective of improved vision at different distances with total spectacle independence. This study aimed to compare the visual acuity at different distances, contrast sensitivity, spectacle needs, photic phenomena, and quality of life parameters of patients bilaterally implanted with a low add bifocal (Tecnis ZKB00) or an EDOF IOL (Tecnis Symfony), both with planned mini-monovision to improve near vision.

Conditions

Multifocal Intraocular Lenses; Extended Depth of Focus

Keywords

low add multifocal intraocular lens, MIOL, ZKB00, extended depth of focus, EDOF, ZXR00, mini-monovision

Outcome Measures

Primary Outcomes (12)

• The visual acuity

  monocular and binocular uncorrected and corrected distance (UDVA, CDVA; at 6 m), intermediate (UIVA, CIVA; at 60 cm), and near (UNVA, CNVA; at 40 cm) logMAR visual acuity were assessed with electronic shelled chart.Distance visual acuity was measured with LCD screen version (CSO Vision Chart, Mod CVC02, version 1.3.0, Florence, Italy) of Snellen Charts under photopic conditions (85 cd/m2). Intermediate and near visual acuities were measured and recorded with a Turkish reading chart prepared with reference to Bailey-Lovie and ETDRS (Early Treatment Diabetic Retinopathy Study) reading charts covering international standards.13 The logMAR values of the chart designed for 35 cm distance were corrected with the formula "log10(standard distance/new distance \[cm\])" according to the distance used (40 and 60 cm).

  Preoperative

• The visual acuity

  monocular and binocular uncorrected and corrected distance (UDVA, CDVA; at 6 m), intermediate (UIVA, CIVA; at 60 cm), and near (UNVA, CNVA; at 40 cm) logMAR visual acuity were assessed with electronic shelled chart.Distance visual acuity was measured with LCD screen version (CSO Vision Chart, Mod CVC02, version 1.3.0, Florence, Italy) of Snellen Charts under photopic conditions (85 cd/m2). Intermediate and near visual acuities were measured and recorded with a Turkish reading chart prepared with reference to Bailey-Lovie and ETDRS (Early Treatment Diabetic Retinopathy Study) reading charts covering international standards.13 The logMAR values of the chart designed for 35 cm distance were corrected with the formula "log10(standard distance/new distance \[cm\])" according to the distance used (40 and 60 cm).

  Postoperative 1st month

• The visual acuity

  monocular and binocular uncorrected and corrected distance (UDVA, CDVA; at 6 m), intermediate (UIVA, CIVA; at 60 cm), and near (UNVA, CNVA; at 40 cm) logMAR visual acuity were assessed with electronic shelled chart.Distance visual acuity was measured with LCD screen version (CSO Vision Chart, Mod CVC02, version 1.3.0, Florence, Italy) of Snellen Charts under photopic conditions (85 cd/m2). Intermediate and near visual acuities were measured and recorded with a Turkish reading chart prepared with reference to Bailey-Lovie and ETDRS (Early Treatment Diabetic Retinopathy Study) reading charts covering international standards.13 The logMAR values of the chart designed for 35 cm distance were corrected with the formula "log10(standard distance/new distance \[cm\])" according to the distance used (40 and 60 cm).

  Postoperative 3rd month

• The visual acuity

  monocular and binocular uncorrected and corrected distance (UDVA, CDVA; at 6 m), intermediate (UIVA, CIVA; at 60 cm), and near (UNVA, CNVA; at 40 cm) logMAR visual acuity were assessed with electronic shelled chart.Distance visual acuity was measured with LCD screen version (CSO Vision Chart, Mod CVC02, version 1.3.0, Florence, Italy) of Snellen Charts under photopic conditions (85 cd/m2). Intermediate and near visual acuities were measured and recorded with a Turkish reading chart prepared with reference to Bailey-Lovie and ETDRS (Early Treatment Diabetic Retinopathy Study) reading charts covering international standards.13 The logMAR values of the chart designed for 35 cm distance were corrected with the formula "log10(standard distance/new distance \[cm\])" according to the distance used (40 and 60 cm).

  Postoperative 6th month

• The contrast sensitivity (CS),

  Contrast sensitivity (CS) was evaluated at 3, 6, 12 and 18 cycle per degree (cpd) spatial frequencies with CSV-1000 E test (VectorVision, Ohio, USA) under mesopic (3.5 candela \[cd\]/m2) conditions at 2.5 m with distance refractive correction. The test was conducted with and without glare, and as a glare source, two halogen lamps located either side of the test chart and producing 2.5 cd/m2 luminance at eye plane were used. CS at different spatial frequencies was compared with the physiologic CS range for normal subjects of similar age. CS was also evaluated with the LCD screen version (CSO Vision Chart, Mod CVC02, version 1.3.0, Florence, Italy) of Pelli-Robson Test (PRT) under photopic (85 cd/m2) and mesopic (3.5 cd/m2) conditions at 3 m monocularly with distance refractive correction. To the best of our knowledge, PRT CS normal values, performed under similar conditions, are not available in the literature, so the data was used only for intergroup comparisons.

  Preoperative

• The contrast sensitivity (CS),

  Contrast sensitivity (CS) was evaluated at 3, 6, 12 and 18 cycle per degree (cpd) spatial frequencies with CSV-1000 E test (VectorVision, Ohio, USA) under mesopic (3.5 candela \[cd\]/m2) conditions at 2.5 m with distance refractive correction. The test was conducted with and without glare, and as a glare source, two halogen lamps located either side of the test chart and producing 2.5 cd/m2 luminance at eye plane were used. CS at different spatial frequencies was compared with the physiologic CS range for normal subjects of similar age. CS was also evaluated with the LCD screen version (CSO Vision Chart, Mod CVC02, version 1.3.0, Florence, Italy) of Pelli-Robson Test (PRT) under photopic (85 cd/m2) and mesopic (3.5 cd/m2) conditions at 3 m monocularly with distance refractive correction. To the best of our knowledge, PRT CS normal values, performed under similar conditions, are not available in the literature, so the data was used only for intergroup comparisons.

  Postoperative 1st month

• The contrast sensitivity (CS),

  Contrast sensitivity (CS) was evaluated at 3, 6, 12 and 18 cycle per degree (cpd) spatial frequencies with CSV-1000 E test (VectorVision, Ohio, USA) under mesopic (3.5 candela \[cd\]/m2) conditions at 2.5 m with distance refractive correction. The test was conducted with and without glare, and as a glare source, two halogen lamps located either side of the test chart and producing 2.5 cd/m2 luminance at eye plane were used. CS at different spatial frequencies was compared with the physiologic CS range for normal subjects of similar age. CS was also evaluated with the LCD screen version (CSO Vision Chart, Mod CVC02, version 1.3.0, Florence, Italy) of Pelli-Robson Test (PRT) under photopic (85 cd/m2) and mesopic (3.5 cd/m2) conditions at 3 m monocularly with distance refractive correction. To the best of our knowledge, PRT CS normal values, performed under similar conditions, are not available in the literature, so the data was used only for intergroup comparisons.

  Postoperative 3rd month

• The contrast sensitivity (CS),

  Contrast sensitivity (CS) was evaluated at 3, 6, 12 and 18 cycle per degree (cpd) spatial frequencies with CSV-1000 E test (VectorVision, Ohio, USA) under mesopic (3.5 candela \[cd\]/m2) conditions at 2.5 m with distance refractive correction. The test was conducted with and without glare, and as a glare source, two halogen lamps located either side of the test chart and producing 2.5 cd/m2 luminance at eye plane were used. CS at different spatial frequencies was compared with the physiologic CS range for normal subjects of similar age. CS was also evaluated with the LCD screen version (CSO Vision Chart, Mod CVC02, version 1.3.0, Florence, Italy) of Pelli-Robson Test (PRT) under photopic (85 cd/m2) and mesopic (3.5 cd/m2) conditions at 3 m monocularly with distance refractive correction. To the best of our knowledge, PRT CS normal values, performed under similar conditions, are not available in the literature, so the data was used only for intergroup comparisons.

  Postoperative 6th month

• Quality of life measurement

  Quality of life parameters were evaluated by the validated Turkish version of the National Eye Institute Refractive Error Quality of Life Instrument 42 (NEI RQL-42) questionnaire. It includes 13 subscales of quality of life parameters calculated according to a scoring key, and a "total score" can be obtained by calculating the mean value of all 42 questions.

  Preoperative

• Quality of life measurement

  Quality of life parameters were evaluated by the validated Turkish version of the National Eye Institute Refractive Error Quality of Life Instrument 42 (NEI RQL-42) questionnaire. It includes 13 subscales of quality of life parameters calculated according to a scoring key, and a "total score" can be obtained by calculating the mean value of all 42 questions.

  Postoperative 1st month

• Quality of life measurement

  Quality of life parameters were evaluated by the validated Turkish version of the National Eye Institute Refractive Error Quality of Life Instrument 42 (NEI RQL-42) questionnaire. It includes 13 subscales of quality of life parameters calculated according to a scoring key, and a "total score" can be obtained by calculating the mean value of all 42 questions.

  Postoperative 3rd month

• Quality of life measurement

  Quality of life parameters were evaluated by the validated Turkish version of the National Eye Institute Refractive Error Quality of Life Instrument 42 (NEI RQL-42) questionnaire. It includes 13 subscales of quality of life parameters calculated according to a scoring key, and a "total score" can be obtained by calculating the mean value of all 42 questions.

  Postoperative 6th month

Study Arms (2)

MIOL Group

ACTIVE COMPARATOR

30 eyes of 15 cataract patients undergoing cataract surgery were implanted with a low add (+2.75 Diopters \[D\]) bifocal (Tecnis ZKB00; Johnson and Johnson Surgical Vision Inc., Jacksonville, Florida, USA) IOL (MIOL Group).

Device: Tecnis +2.75 D (ZKB00) and Tecnis Symfony (ZXR00)

EDOF Group

ACTIVE COMPARATOR

30 eyes of 15 cataract patients undergoing cataract surgery were implanted with an EDOF (Tecnis Symfony \[ZXR00\]; Johnson and Johnson Surgical Vision Inc., Jacksonville, Florida, USA) IOL (EDOF Group).

Device: Tecnis +2.75 D (ZKB00) and Tecnis Symfony (ZXR00)

Interventions

Tecnis +2.75 D (ZKB00) and Tecnis Symfony (ZXR00) DEVICE

This study included 30 eyes of 15 cataract patients undergoing cataract surgery with implantation of a low add (+2.75 Diopters \[D\]) bifocal (Tecnis ZKB00; Johnson and Johnson Surgical Vision Inc., Jacksonville, Florida, USA) IOL (MIOL Group) and 30 eyes of 15 patients with implantation of an EDOF (Tecnis Symfony \[ZXR00\]; Johnson and Johnson Surgical Vision Inc., Jacksonville, Florida, USA) IOL (EDOF Group).

EDOF Group; MIOL Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patients were excluded from the study if any of the following conditions were present: high visual demand for near vision, amblyopia, glaucoma, corneal opacity, severe/moderate to severe dry eye, pupillary abnormalities and dysfunction, corneal astigmatism ≥1.00 D, AL \<21 mm or ≥26.5 mm, diabetes mellitus with retinal changes, active uveitis or history of uveitis, previous ocular surgery and lack of attendance to any follow-up visit.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University School of Medicine, Department of Ophthalmology

Istanbul, 34854, Turkey (Türkiye)

Location

Related Publications (4)

• Rosen E, Alio JL, Dick HB, Dell S, Slade S. Efficacy and safety of multifocal intraocular lenses following cataract and refractive lens exchange: Metaanalysis of peer-reviewed publications. J Cataract Refract Surg. 2016 Feb;42(2):310-28. doi: 10.1016/j.jcrs.2016.01.014.

  PMID: 27026457 BACKGROUND

• Kim JS, Jung JW, Lee JM, Seo KY, Kim EK, Kim TI. Clinical Outcomes Following Implantation of Diffractive Multifocal Intraocular Lenses With Varying Add Powers. Am J Ophthalmol. 2015 Oct;160(4):702-9.e1. doi: 10.1016/j.ajo.2015.07.021. Epub 2015 Jul 21.

  PMID: 26209232 BACKGROUND

• Kretz FT, Gerl M, Gerl R, Muller M, Auffarth GU; ZKB00 Study Group. Clinical evaluation of a new pupil independent diffractive multifocal intraocular lens with a +2.75 D near addition: a European multicentre study. Br J Ophthalmol. 2015 Dec;99(12):1655-9. doi: 10.1136/bjophthalmol-2015-306811. Epub 2015 May 18.

  PMID: 25987651 BACKGROUND

• Pedrotti E, Bruni E, Bonacci E, Badalamenti R, Mastropasqua R, Marchini G. Comparative Analysis of the Clinical Outcomes With a Monofocal and an Extended Range of Vision Intraocular Lens. J Refract Surg. 2016 Jul 1;32(7):436-42. doi: 10.3928/1081597X-20160428-06.

  PMID: 27400074 BACKGROUND

Study Officials

• Ayse Ebru Toker, Professor

  Marmara University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: April 29, 2021
• Study Start: October 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: March 1, 2019
• Last Updated: April 29, 2021

Record last verified: 2021-04

Locations

TU (1)