NCT06937489

Brief Summary

Toric SCL combined spheric lens power with cylinder power and axis. However, in Indonesia, the availability of cylinder power and axis parameter variations between products are still narrow, with stock-keeping units (SKUs) options only between 0.75-2.75 DC and 10o-180o for power and axis, respectively. Providing accurate toric SCL prescription for astigmatism patient in Indonesia remains a challenge for ophthalmologists and generally could not be achieved. Therefore, the aim of this study is to investigate the effect of power undercorrection and axis misalignment on visual acuity, contrast sensitivity, visual clarity, visual satisfaction, and vision acceptability. The inclusion criteria for the trial, include: (1) 20 to 40 years of age without the need for presbyopic correction, (2) mild to moderate myopia patients, sphere between -1.00 and - 6.00 D combined with cylinder between -0.75 to -3.00 DC in at least one eye, (3) corrected distance visual acuity (VA) of with Toric SCL 6/15 or better bilaterally. Exclusion criteria include: (1) a history of contact lens use 6 months prior to trial, (2) history of previous ocular surgery, (3) anterior and posterior segment abnormalities, (4) manifest strabismus or dry eye, and (5) ocular and systemic diseases that would preclude CL wear or decrease visual acuity; and pregnancy or lactation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 16, 2020

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2020

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2020

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

April 20, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 22, 2025

Completed
Last Updated

April 22, 2025

Status Verified

April 1, 2025

Enrollment Period

26 days

First QC Date

April 20, 2025

Last Update Submit

April 20, 2025

Conditions

Astigmatism

Keywords

astigmatismtoric contact lensaxis misalignmentvisual acuity

Outcome Measures

Primary Outcomes (5)

  • Visual acuity

    Visual acuity was measured using Snellen chart and reported with logMAR

    Week 1 and week 2

  • Contrast sensitivity was measured using Pelli-Robson chart,

    Contrast sensitivity was measured using Pelli-Robson chart,

    Week 1 and week 2

  • Monocular clarity

    VAS (Visual Analog Scale, with 10 being the best indicator) was utilized to measure monocular clarity (1=blurred, 10=clear)

    Week 1 and week 2

  • Visual satisfaction

    VAS (Visual Analog Scale, with 10 being the best indicator) was utilized to measure visual satisfaction (1=satisfied, 10=unsatisfied)

    Week 1 and week 2

  • Vision acceptability

    VAS (Visual Analog Scale, with 10 being the best indicator) was utilized to measure vision acceptability (1=unacceptable, 10=perfectly acceptable).

    Week 1 and week 2

Study Arms (2)

Undercorrection of toric soft contact lens

EXPERIMENTAL

A disposable toric lens investigated in this work is 2-Weeks Acuvue Moist for Astigmatism (2WAMfA), a common hydrogel conventional toric lenses.

Device: Hydrogel conventional toric lenses with undercorrection of 0.5 DDevice: Hydrogel conventional toric lenses with undercorrection of 1.0 D

Axis misalignment of toric soft contact lens

ACTIVE COMPARATOR

A disposable toric lens investigated in this work is 2-Weeks Acuvue Moist for Astigmatism (2WAMfA), a common hydrogel conventional toric lenses.

Device: Hydrogel conventional toric lenses with -10° axis misalignmentDevice: Hydrogel conventional toric lenses with +10° axis misalignment

Interventions

Hydrogel conventional toric lenses with +10° axis misalignmentDEVICE

The assessment visits interval is 1 week and completed exactly on day 14 after their first baseline visit. At each assessment visit, three different cylinder power were tested: 1) full cylinder power, 2) under-correction of cylinder power by 0.5 D, and 3) under-correction of cylinder power by 1.0 DC. Axis was also misaligned by -10° and +10° for each cylinder power alteration. The powers and axis assigned to the participants were randomized during every assessment visit. Baseline assessments and treatment allocations were masked to both patients and physician. All assessments were carried out on the day of observation and recorded on the subject evaluation sheet in accordance with the sample data, in which examinations results.

Axis misalignment of toric soft contact lens
Hydrogel conventional toric lenses with undercorrection of 0.5 DDEVICE

The assessment visits interval is 1 week and completed exactly on day 14 after their first baseline visit. At each assessment visit, three different cylinder power were tested: 1) full cylinder power, 2) under-correction of cylinder power by 0.5 D, and 3) under-correction of cylinder power by 1.0 DC. Axis was also misaligned by -10° and +10° for each cylinder power alteration. The powers and axis assigned to the participants were randomized during every assessment visit. Baseline assessments and treatment allocations were masked to both patients and physician. All assessments were carried out on the day of observation and recorded on the subject evaluation sheet in accordance with the sample data, in which examinations results.

Undercorrection of toric soft contact lens
Hydrogel conventional toric lenses with undercorrection of 1.0 DDEVICE

The assessment visits interval is 1 week and completed exactly on day 14 after their first baseline visit. At each assessment visit, three different cylinder power were tested: 1) full cylinder power, 2) under-correction of cylinder power by 0.5 D, and 3) under-correction of cylinder power by 1.0 DC. Axis was also misaligned by -10° and +10° for each cylinder power alteration. The powers and axis assigned to the participants were randomized during every assessment visit. Baseline assessments and treatment allocations were masked to both patients and physician. All assessments were carried out on the day of observation and recorded on the subject evaluation sheet in accordance with the sample data, in which examinations results.

Undercorrection of toric soft contact lens

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • to 40 years of age without the need for presbyopic correction
  • mild to moderate myopia patients, sphere between -1.00 and - 6.00 D combined with cylinder between -0.75 to -3.00 DC in at least one eye
  • corrected distance visual acuity (VA) of with Toric SCL 6/15 or better bilaterally.

You may not qualify if:

  • a history of contact lens use 6 months prior to trial
  • history of previous ocular surgery
  • anterior and posterior segment abnormalities
  • manifest strabismus or dry eye
  • ocular and systemic diseases that would preclude CL wear or decrease visual acuity; and pregnancy or lactation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, Faculty of Medicine Universitas Indonesia Cipto Mangunkusumo Hospital, Indonesia

Jakarta, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Tri Rahayu, MD

    Department of Ophthalmology, Faculty of Medicine Universitas Indonesia Cipto Mangunkusumo Hospital, Indonesia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The participants, the ophthalmologist conducting the eye examinations, and the outcome assessors will be blinded to group allocation.
Purpose
DEVICE FEASIBILITY
Intervention Model
CROSSOVER
Model Details: This study will compare the effect of undercorrection and axis misalignment of toric SCL in mild and moderate astigmatism on visual acuity, contrast sensitivity, visual satisfaction, and vision acceptability.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ophthalmologist at the Department of Ophthalmology, Faculty of Medicine Universitas Indonesia Cipto Mangunkusumo Hospital, Indonesia

Study Record Dates

First Submitted

April 20, 2025

First Posted

April 22, 2025

Study Start

November 16, 2020

Primary Completion

December 12, 2020

Study Completion

December 19, 2020

Last Updated

April 22, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Due to patient privacy and blinding method, IPD will not be shared.

Locations

ID(1)