AstigmatismNCT06937489
The Effect of the Changes in Cylinder Power and Axis of Toric Soft Contact Lenses on the Visual Quality, Satisfaction and Vision Acceptability in Astigmatic Subjects
A study testing Hydrogel conventional toric lenses with -10° axis misalignment, Hydrogel conventional toric lenses with +10° axis misalignment and Hydrogel conventional toric lenses with undercorrection of 0.5 D in people with Astigmatism, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Astigmatism
- What is being tested?
- Hydrogel conventional toric lenses with -10° axis misalignment, Hydrogel conventional toric lenses with +10° axis misalignment and Hydrogel conventional toric lenses with undercorrection of 0.5 D
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIndonesia
- Study dates
- 16 Nov 2020to 19 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 20 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Department of Ophthalmology, Faculty of Medicine Universitas Indonesia Cipto Mangunkusumo Hospital, Indonesia
Jakarta, DKI Jakarta, 10430
About this study
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.
Read the detailed description
Detailed Procedure
Baseline refraction and clinical manifestations were determined during initial visit which each participants attended three assessment visits on a separate day. Baseline visual acuity was measured using Snellen chart, contrast sensitivity was measured using Pelli-Robson chart, and VAS (Visual Analog Scale, with 10 being the best indicator) was utilized to measure monocular clarity (1=blurred, 10=clear), satisfaction (1=satisfied, 10=unsatisfied), and vision acceptability (1=unacceptable, 10=perfectly acceptable).
Participants were fitted on their diseased eye, which could be unilateral or bilateral, with the toric SCL. Lens fit (corneal coverage, centration, movement, and rotation) was examined using slit-lamp examination. Regarding lens rotation, modification of the toric SCL axis was determined using the "LARS" (left add, right subtract) method for proper contact lens fitting. The shifting axis in toric SCL was assessed by observing the shift marker on contact lens in a clockwise or anticlockwise direction; then if any, it was corrected using LARS formula. A disposable toric lens investigated in this work is 2-Weeks Acuvue Moist for Astigmatism (2WAMfA), a common hydrogel conventional toric lenses.
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.
- Conditions
- Astigmatism
- Being tested
- Hydrogel conventional toric lenses with -10° axis misalignment, Hydrogel conventional toric lenses with +10° axis misalignment, Hydrogel conventional toric lenses with undercorrection of 0.5 D, Hydrogel conventional toric lenses with undercorrection of 1.0 D
- Keywords
- astigmatism, toric contact lens, axis misalignment, visual acuity
- Medical subject headings
- Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Hydrogel conventional toric lenses with undercorrection of 0.5 D; Device: 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. Receives: Device: Hydrogel conventional toric lenses with -10° axis misalignment; Device: Hydrogel conventional toric lenses with +10° axis misalignment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Visual acuity was measured using Snellen chart and reported with logMAR
Measured: Week 1 and week 2
Contrast sensitivity was measured using Pelli-Robson chart,
Contrast sensitivity was measured using Pelli-Robson chart,
Measured: 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)
Measured: 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)
Measured: 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).
Measured: Week 1 and week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start16 Nov 2020
- Primary completion12 Dec 2020
- Study completion19 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AstigmatismStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr. Tri Rahayu, SpM(K), FIACLE, Universitas Indonesia
- Investigators
- Tri Rahayu, MD, Principal investigator, Department of Ophthalmology, Faculty of Medicine Universitas Indonesia Cipto Mangunkusumo Hospital, Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06937489
- Sponsor's protocol ID
- 20-07-0813
- Other IDs
- PUTI Saintekes 2020 Grant
- Status last verified
- Apr 2025
- First submitted
- 20 Apr 2025
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to patient privacy and blinding method, IPD will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Changes in Cylinder Power and Axis of Toric Soft Contact Lenses on the Visual Quality, Satisfaction and Vision Acceptability in Astigmatic Subjects
- ClinicalTrials.gov ID
- NCT06937489
- Acronym / sponsor ID
- 20-07-0813
- Conditions
- Astigmatism
- Keywords
- astigmatism, toric contact lens, axis misalignment, visual acuity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- 12 Dec 2020 (actual)
- Study completion
- 19 Dec 2020 (actual)
- First posted
- 22 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Detailed Procedure
Baseline refraction and clinical manifestations were determined during initial visit which each participants attended three assessment visits on a separate day. Baseline visual acuity was measured using Snellen chart, contrast sensitivity was measured using Pelli-Robson chart, and VAS (Visual Analog Scale, with 10 being the best indicator) was utilized to measure monocular clarity (1=blurred, 10=clear), satisfaction (1=satisfied, 10=unsatisfied), and vision acceptability (1=unacceptable, 10=perfectly acceptable).
Participants were fitted on their diseased eye, which could be unilateral or bilateral, with the toric SCL. Lens fit (corneal coverage, centration, movement, and rotation) was examined using slit-lamp examination. Regarding lens rotation, modification of the toric SCL axis was determined using the "LARS" (left add, right subtract) method for proper contact lens fitting. The shifting axis in toric SCL was assessed by observing the shift marker on contact lens in a clockwise or anticlockwise direction; then if any, it was corrected using LARS formula. A disposable toric lens investigated in this work is 2-Weeks Acuvue Moist for Astigmatism (2WAMfA), a common hydrogel conventional toric lenses.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Undercorrection of toric soft contact lens | Experimental | Device: Hydrogel conventional toric lenses with undercorrection of 0.5 D, Device: Hydrogel conventional toric lenses with undercorrection of 1.0 DA disposable toric lens investigated in this work is 2-Weeks Acuvue Moist for Astigmatism (2WAMfA), a common hydrogel conventional toric lenses. |
| Axis misalignment of toric soft contact lens | Active comparator | Device: Hydrogel conventional toric lenses with -10° axis misalignment, Device: Hydrogel conventional toric lenses with +10° axis misalignmentA disposable toric lens investigated in this work is 2-Weeks Acuvue Moist for Astigmatism (2WAMfA), a common hydrogel conventional toric lenses. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 20 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrogel conventional toric lenses with -10° axis misalignmentThe 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. | Device | Axis misalignment of toric soft contact lens |
| Hydrogel conventional toric lenses with +10° axis misalignmentThe 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. | Device | Axis misalignment of toric soft contact lens |
| Hydrogel conventional toric lenses with undercorrection of 0.5 DThe 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. | Device | Undercorrection of toric soft contact lens |
| Hydrogel conventional toric lenses with undercorrection of 1.0 DThe 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. | Device | Undercorrection of toric soft contact lens |
Primary outcome
Visual acuity
Time frame: Week 1 and week 2
Visual acuity was measured using Snellen chart and reported with logMAR
Contrast sensitivity was measured using Pelli-Robson chart,
Time frame: Week 1 and week 2
Contrast sensitivity was measured using Pelli-Robson chart,
Monocular clarity
Time frame: Week 1 and week 2
VAS (Visual Analog Scale, with 10 being the best indicator) was utilized to measure monocular clarity (1=blurred, 10=clear)
Visual satisfaction
Time frame: Week 1 and week 2
VAS (Visual Analog Scale, with 10 being the best indicator) was utilized to measure visual satisfaction (1=satisfied, 10=unsatisfied)
Vision acceptability
Time frame: Week 1 and week 2
VAS (Visual Analog Scale, with 10 being the best indicator) was utilized to measure vision acceptability (1=unacceptable, 10=perfectly acceptable).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2025.
- Individual participant dataSharing planned: No. Due to patient privacy and blinding method, IPD will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tri Rahayu, MD principal investigator
Department of Ophthalmology, Faculty of Medicine Universitas Indonesia Cipto Mangunkusumo Hospital, Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrogel conventional toric lenses with -10° axis misalignment, Hydrogel conventional toric lenses with +10° axis misalignment and Hydrogel conventional toric lenses with undercorrection of 0.5 D in people with Astigmatism, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity (time frame: Week 1 and week 2). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2025.