NCT02595177

Brief Summary

To compare refractive outcomes and patient's visual quality after bilateral cataract surgery when implanting multifocal intraocular lens, monofocal with monovision or hybrid monovision.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 3, 2015

Completed
Last Updated

November 3, 2015

Status Verified

November 1, 2015

Enrollment Period

1.2 years

First QC Date

October 27, 2015

Last Update Submit

November 1, 2015

Conditions

CataractPresbyopia

Keywords

multifocal IOLmonovisionhybrid monovisionspectacles independence

Outcome Measures

Primary Outcomes (1)

  • Visual acuity

    Binocular visual acuity in a semi-darkened room without correction to far, intermediate and near using a typical Snellen chart that is frequently used for visual acuity testing.

    1 year

Secondary Outcomes (4)

  • Speed reading measure

    1 year

  • Near stereopsis measure

    1 year

  • Contrast sensitivity measure

    1 year

  • National Eye Institute Visual Functioning Questionnaire - 25 (VFQ-25) questionnaire

    1 year

Study Arms (3)

Multifocal IOL

EXPERIMENTAL

Cataract removal with topical anesthesia and phacoemulsification is performed. At the end, multifocal intraocular lens implantation in both eyes planning for emmetropia complete the intervention.

Procedure: Cataract surgery with intraocular lens implantation.

Monovision

EXPERIMENTAL

Cataract removal with topical anesthesia and phacoemulsification is performed. At the end, a monofocal intraocular lens implantation planning for emmetropia in one eye (dominant) and a monofocal IOL planning for 1.50 D of myopia in the other eye (non-dominant) complete the intervention.

Procedure: Cataract surgery with intraocular lens implantation.

Hybrid Monovision

EXPERIMENTAL

Cataract removal with topical anesthesia and phacoemulsification is performed. At the end, a monofocal intraocular lens implantation in the dominant eye and a multifocal IOL in the non-dominant eye complete the intervention.

Procedure: Cataract surgery with intraocular lens implantation.

Interventions

Cataract surgery with intraocular lens implantation.PROCEDURE

Phacoemulsification under topical anesthesia with intraocular lens implantation.

Hybrid MonovisionMonovisionMultifocal IOL

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Bilateral senile cataracts.
  • Implantation of IOL in the capsular bag;
  • Implants from 10-30 diopter;
  • Potential Visual Acuity in ≥ 0.2 logMAR (20/32, metric scale) after surgery;

You may not qualify if:

  • Amblyopia;
  • Single Eye;
  • History of intraocular surgery in the previous year;
  • Sequel to prior ocular trauma;
  • Important Microphthalmia or aniridia;
  • History of damage to the corneal endothelium (chemical burns, herpetic keratitis, corneal guttata);
  • Corneal astigmatism \> 1.0 D;
  • IOP ≥ 21 mmHg in standard caliper;
  • Ocular pathology that affects visual function (uveitis, diabetic retinopathy, age-related macular degeneration, macular dystrophy, retinal detachment, glaucoma, optic neuropathy);
  • Pupil \> 5 mm or \< 2 mm under photopic conditions;
  • Asymmetrical pupils in the eye or between the eyes;
  • Binocular vision absence;
  • Any situation that endangers the implant position in the capsular bag (post-traumatic zonular weakness, pseudoexfoliation, for example);
  • Patient probably need to laser treatment of the retina;
  • Patients whose expectations are unrealistic;
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology and Visual Sciences from the Federal University of Sao Paulo (UNIFESP)

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

CataractPresbyopia

Interventions

Cataract ExtractionLens Implantation, Intraocular

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesRefractive Errors

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Joao Crispim, MD

    Post graduated

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post graduated

Study Record Dates

First Submitted

October 27, 2015

First Posted

November 3, 2015

Study Start

July 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

November 3, 2015

Record last verified: 2015-11

Locations

BR(1)