NCT03633851

Brief Summary

The purpose of the study is to compare the astigmatism reducing effect of a toric intraocular lens (IOL) (model MX60T - Bausch \& Lomb) with that of limbal relaxing incisional surgery combined with a non toric IOL (model MX60 - Bausch \& Lomb) in patients with corneal astigmatism between 1.0 and 1.5 diopters and also the effect of cylinder reduction on patient's quality of vision.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

October 3, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2018

Completed
7 months until next milestone

First Posted

Study publicly available on registry

August 16, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

August 16, 2018

Status Verified

August 1, 2018

Enrollment Period

1.8 years

First QC Date

February 2, 2018

Last Update Submit

August 14, 2018

Conditions

Corneal Astigmatism

Outcome Measures

Primary Outcomes (2)

  • Astigmatism reduction effect of toric intraocular lens (IOL) versus non-toric IOL with limbal relaxing incisions.

    Astigmatism reduction will be evaluated with optical biometry, corneal topography

    6 months and 12 months

  • Astigmatism reduction effect of toric intraocular lens (IOL) versus non-toric IOL

    Astigmatism reduction will be evaluated with manifest refraction, autorefraction

    6 months and 12 months

Secondary Outcomes (6)

  • Unaided visual acuity after toric intraocular lens (IOL) versus non-toric IOL with limbal relaxing incisions.

    6 months and 12 months

  • Best-spectacle corrected visual acuity after toric intraocular lens (IOL) versus non-toric IOL with limbal relaxing incisions.

    6 months and 12 months

  • Quality of Vision

    6 months and 12 months

  • Visual disability

    6 months and 12 months

  • Overall satisfaction

    6 months and 12 months

  • +1 more secondary outcomes

Study Arms (2)

Toric intraocular MX60T lens

EXPERIMENTAL

one eye will receive toric MX60T lens

Device: Toric intraocular MX60T lens

Standard MX60 plus corneal incisions

OTHER

the other eye will receive standard MX60 lens with corneal incisions

Other: Standard MX60 plus corneal incisions

Interventions

Toric intraocular MX60T lensDEVICE

one eye will receive toric MX60T lens

Toric intraocular MX60T lens
Standard MX60 plus corneal incisionsOTHER

the other eye will receive standard MX60 lens with corneal incisions

Standard MX60 plus corneal incisions

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Bilateral cataract.
  • Age 21 and older.
  • Written informed consent to sequential bilateral surgery and participation in the study.
  • Preoperative pupil size greater than or equal to 5.0 mm in the study eye.
  • IOL power as predicted by biometry ranging from 6.0 D to 30.0 D in both eyes.
  • Regular corneal astigmatism according to Orbscan topography.
  • Postoperative corneal astigmatism between 0.90 D and 1.40 D in both eyes, as predicted by the Bausch + Lomb Toric Calculator (https://envista.toriccalculator.com).

You may not qualify if:

  • Ocular comorbidity (corneal scars, amblyopia, retina, or optic nerve disease) that may reduce postoperative CDVA
  • Reduced zonular or capsular stability (e.g. Marfan syndrome, previous eye trauma)
  • Irregular corneal astigmatism on Orbscan topography

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr Isaac John

Chertsey, Surrey, KT16 0PZ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Vinod Gangwani, MBBS FRCS

    Ashford and St. Peter's Hospitals NHS Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Isaac John, PhD

CONTACT

0044 193 272 2901Isaac.John@nhs.net

Freda Gomes, MSc

CONTACT

0044 193 272 6664Freda.Gomes@nhs.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2018

First Posted

August 16, 2018

Study Start

October 3, 2017

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

August 16, 2018

Record last verified: 2018-08

Locations

GB(1)