NCT03726606

Brief Summary

We are conducting a trial evaluating the performance of trifocal versus extended depth of focus intraocular lenses. These lenses will be implanted in otherwise healthy individuals with visual problems due to bilateral cataracts. Patients must be seeking an improvement in their visual performance with a special focus on presbyopia correction.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

October 29, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 31, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

November 5, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 6, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2019

Completed
Last Updated

October 31, 2018

Status Verified

October 1, 2018

Enrollment Period

6 months

First QC Date

October 29, 2018

Last Update Submit

October 30, 2018

Conditions

CataractLensesVisual Impairment

Keywords

CataractIntraocular lensesTrifocal intraocular lensesExtended depth of focus intraocular lensesPresbyopia

Outcome Measures

Primary Outcomes (3)

  • Near Visual Acuity (Corrected and Uncorrected)

    40 cm

    3 months after bilateral implantation

  • Intermediate Visual Acuity (Corrected and Uncorrected)

    66 cm

    3 months after bilateral implantation

  • Distance Visual Acuity (Corrected and Uncorrected)

    4 m

    3 months after bilateral implantation

Secondary Outcomes (5)

  • Defocus Curve

    3 months after bilateral implantation

  • Objective Automated Refraction

    3 months after bilateral implantation

  • Contrast Sensitivity

    3 months after bilateral implantation

  • Higher Order Abberations

    3 months after bilateral implantation

  • Halos and Glares

    3 months after bilateral implantation

Study Arms (2)

Extended depth of focus intraocular lens

EXPERIMENTAL

Bilateral implantation of extended depth of focus intraocular lenses.

Device: Intraocular lens

Trifocal intraocular lens

ACTIVE COMPARATOR

Bilateral implantation of trifocal intraocular lenses.

Device: Intraocular lens

Interventions

Intraocular lensDEVICE

Bilateral implantation of the same intraocular lens.

Also known as: Phacoemulsifcation
Extended depth of focus intraocular lensTrifocal intraocular lens

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient aged 30 years of age or older
  • Has bilateral cataracts with visual problems
  • Is motivated for vision correction

You may not qualify if:

  • Any ocular pathology that could impair vision, for example:
  • Pseudoexfoliation syndrome
  • Zonular weakness
  • Retinal or corneal dystrophies
  • Retinal pathologies like age related macular degeneration
  • History of trauma
  • History of ocular surgery
  • Individuals having trouble understanding written or spoken language
  • Those with dense cataracts causing problems with optical biometry
  • Average corneal powers outside the range of 41 diopters (D) to 46 D
  • Corneal astigmatism \> 0.75 D
  • Irregular astigmatism index of 0.54 or higher

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

CataractVision DisordersPresbyopia

Interventions

Lenses, Intraocular

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsRefractive Errors

Intervention Hierarchy (Ancestors)

LensesOptical DevicesEquipment and SuppliesProstheses and Implants

Study Officials

  • Sharif Hashmani, FCPS

    Hashmanis Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nauman Hashmani, MBBS

CONTACT

00923212828062naumanhashmani@hashmanis.edu.pk

Sharif Hashmani, FCPS

CONTACT

00923008255771yashhashmani@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The patient and the examiner will be blinded to the arms.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly allocated to one of two arms: Trifocal or extended depth of focus intraocular lenses.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2018

First Posted

October 31, 2018

Study Start

November 5, 2018

Primary Completion

May 6, 2019

Study Completion

May 6, 2019

Last Updated

October 31, 2018

Record last verified: 2018-10