Visual Acuity Reduced TransientlyNCT04724525
Changes in Power and Cylinder Axis of Toric Soft Contact Lenses (LKL)
A study testing soft contact lens Toric in people with Visual Acuity Reduced Transiently, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
Astigmatism is a common refractive error resulting from a toric-surfaced cornea which using a toric soft contact lens could be one of the therapy options. Due to the numerous possible combinations between sphere powers, cylinder powers, and cylinder axes, manufacturers of disposable soft toric contact lenses limit… Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Acuity Reduced Transiently
- What is being tested?
- soft contact lens Toric
- How many people
- 20 participants
- Where
- 1 siteIndonesia
- Study dates
- 17 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients aged 20 - 35 years
- Patients who do not have a spherical size (plano) to mild-moderate myopia (-1.00 D to -6.00 D) with age over 18 years
- Minimum astigmatism component ≥0.75 D and maximum ≤ 3 D in one eye
- The best visual acuity after corrected by LKL Torik is better or equal to 6/15
Who cannot join
- History of previous intraocular surgery.
- History of contact lens use in the last 6 months.
- history of dry eyes, uveitis, glaucoma and corneal and conjunctival disorders
- posterior segment abnormalities that reduce the quality of vision
- Patients with contraindications to wearing contact lenses
- There are no toric LKLs with exactly the strength and axes required by the patient
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Universitas Indonesia
Jakarta Pusat, Jakarta Special Capital Region, 10430
About this study
Official title: The Effect of Changes in Power and Cylinder Axis on Vision Quality, Satisfaction and Vision Acceptability of People With Mild-Medium Astigmatism With Toric Soft Contact Lenses (LKL)
Astigmatism is a common refractive error resulting from a toric-surfaced cornea which using a toric soft contact lens could be one of the therapy options. Due to the numerous possible combinations between sphere powers, cylinder powers, and cylinder axes, manufacturers of disposable soft toric contact lenses limit their toric lens range, while still aiming to cater to the majority of astigmatic patients. Due to that reason, the possibility of astigmatism patients getting a different combination of power and axis with toric soft contact lenses sold on the market will be high due to SKU limitations. This research aims to ascertain the impact of altering cylinder power and axis on visual quality and convenience in astigmatism participants using toric soft contact lens. The study was conducted at Kirana Ciptomangunkusumo Hospital, Jakarta, starting in April 2020. The study is a prospective, randomized, participant-masked, crossover clinical trial where the participants were tested for the following conditions on different days using full spherocylinder correction and under-correction by 0.25, 0.50, and 0.75 DC while maintaining spherical equivalence. Axis was also misaligned between -30° and +30°, in 10° steps. For each visit, the patient was examined visual acuity, contrast visual acuity using the Pelli-Robson, and assessed patient comfort using the VAS method.
- Conditions
- Visual Acuity Reduced Transiently
- Being tested
- soft contact lens Toric
- Keywords
- Toric soft contact lens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
soft contact lens ToricOther
soft contact lens toric with different axis and power that use in human's eye
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Acuity
Visual acuity was measured using a Snellen chart at a distance of 6 meters by the researcher (DA) at Refractive Poly
Measured: when using a contact lens (0 day,7 days, 14 days)
Secondary outcomes (3)
Change in Contrast sensitivity
Value obtained on examination of the Pelli Robson Chart in Poly Neurooftlamology. Examination conducted by researchers (DA).
Measured: when using a contact lens (0 day,7 days, 14 days)
Visual Clarity
Values were obtained by the VAS method. Research subjects were asked to name a number from 1-10 (score 1 indicates poor clarity, 10 indicates good clarity) to assess visual clarity
Measured: when using a contact lens (0 day,7 days, 14 days)
Visual Satisfaction
Values were obtained by the VAS method. The research subjects were asked to name a number from 1-10 (a score of 1 indicates dissatisfaction, 10 indicates very satisfied)
Measured: when using a contact lens (0 day,7 days, 14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start17 Nov 2020
- Primary completion19 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 Visual Acuity Reduced TransientlyStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dwie Aprina, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04724525
- Sponsor's protocol ID
- 20-070-0813
- Status last verified
- Jan 2021
- First submitted
- 21 Jan 2021
- Last updated
- 1 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Changes in Power and Cylinder Axis on Vision Quality, Satisfaction and Vision Acceptability of People With Mild-Medium Astigmatism With Toric Soft Contact Lenses (LKL)
- ClinicalTrials.gov ID
- NCT04724525
- Acronym / sponsor ID
- 20-070-0813
- Conditions
- Visual Acuity Reduced Transiently
- Keywords
- Toric soft contact lens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 17 Nov 2020 (actual)
- Primary completion
- 19 Dec 2020 (actual)
- Study completion
- 19 Dec 2020 (actual)
- First posted
- 26 Jan 2021 (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.
Astigmatism is a common refractive error resulting from a toric-surfaced cornea which using a toric soft contact lens could be one of the therapy options. Due to the numerous possible combinations between sphere powers, cylinder powers, and cylinder axes, manufacturers of disposable soft toric contact lenses limit their toric lens range, while still aiming to cater to the majority of astigmatic patients. Due to that reason, the possibility of astigmatism patients getting a different combination of power and axis with toric soft contact lenses sold on the market will be high due to SKU limitations. This research aims to ascertain the impact of altering cylinder power and axis on visual quality and convenience in astigmatism participants using toric soft contact lens. The study was conducted at Kirana Ciptomangunkusumo Hospital, Jakarta, starting in April 2020. The study is a prospective, randomized, participant-masked, crossover clinical trial where the participants were tested for the following conditions on different days using full spherocylinder correction and under-correction by 0.25, 0.50, and 0.75 DC while maintaining spherical equivalence. Axis was also misaligned between -30° and +30°, in 10° steps. For each visit, the patient was examined visual acuity, contrast visual acuity using the Pelli-Robson, and assessed patient comfort using the VAS method.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients aged 20 - 35 years
- Patients who do not have a spherical size (plano) to mild-moderate myopia (-1.00 D to -6.00 D) with age over 18 years
- Minimum astigmatism component ≥0.75 D and maximum ≤ 3 D in one eye
- The best visual acuity after corrected by LKL Torik is better or equal to 6/15
Key exclusion criteria (6 listed)
- History of previous intraocular surgery.
- History of contact lens use in the last 6 months.
- history of dry eyes, uveitis, glaucoma and corneal and conjunctival disorders
- posterior segment abnormalities that reduce the quality of vision
- Patients with contraindications to wearing contact lenses
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 |
|---|---|---|
| soft contact lens Toricsoft contact lens toric with different axis and power that use in human's eye | Other | – |
Primary outcome
Change in Visual Acuity
Time frame: when using a contact lens (0 day,7 days, 14 days)
Visual acuity was measured using a Snellen chart at a distance of 6 meters by the researcher (DA) at Refractive Poly
3 secondary outcomes
Change in Contrast sensitivity
Time frame: when using a contact lens (0 day,7 days, 14 days)
Visual Clarity
Time frame: when using a contact lens (0 day,7 days, 14 days)
Visual Satisfaction
Time frame: when using a contact lens (0 day,7 days, 14 days)
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 1 Feb 2021.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing soft contact lens Toric in people with Visual Acuity Reduced Transiently, 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 4 inclusion and 6 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 1 Feb 2021. 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?
Change in Visual Acuity (time frame: when using a contact lens (0 day,7 days, 14 days)). 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 1 Feb 2021.