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

NACompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

November 16, 2020

Primary Completion Date

December 12, 2020

Study Completion Date

December 19, 2020

Conditions
Astigmatism
Interventions
DEVICE

Hydrogel conventional toric lenses with -10° axis misalignment

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.

DEVICE

Hydrogel conventional toric lenses with +10° axis misalignment

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.

DEVICE

Hydrogel conventional toric lenses with undercorrection of 0.5 D

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.

DEVICE

Hydrogel conventional toric lenses with undercorrection of 1.0 D

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.

Trial Locations (1)

10430

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

All Listed Sponsors
lead

Indonesia University

OTHER

NCT06937489 - 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 | Biotech Hunter | Biotech Hunter