Low Cylinder Toric
Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT00732030
Collaborator
(none)
26
1
1
Study Details
Study Description
Brief Summary
Study evaluates the visual outcomes and patient satisfaction after implantation of a toric intraocular lens (IOL).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
26 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation of the Acrysof Toric Model SN60T3 Intraocular Lens in Patients With Predicted Residual Corneal Astigmatism Between 0.75 and 1.03 Diopters (D)
Study Start Date
:
Jun 1, 2007
Actual Primary Completion Date
:
Mar 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: AcrySof Toric T3 Each enrolled eye receives AcrySof Toric Model SN60T3 Intraocular Lens (IOL) |
Device: Toric IOL (SN60T3)
Each enrolled eye implanted with the AcrySof Toric Model SN60T3 intraocular lens (IOL) for the treatment of cataract.
|
Outcome Measures
Primary Outcome Measures
- Uncorrected Distance Visual Acuity [6 months]
Uncorrected Distance Visual Acuity at month 6 measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". It is a unit of measure for visual acuity (VA).
- Best Corrected Distance Visual Acuity [6 Months]
Best Corrected Distance Visual Acuity at month 6 measured in LogMAR. LogMAR is the "logarithm of the minimum angle of resolution". It is a unit of measure for visual acuity (VA).
- Residual Refractive Cylinder [6 Month]
Residual Refractive Cylinder at month 6 measured in diopters (D).
Secondary Outcome Measures
- Patient Satisfaction Survey [6 months]
Satisfaction for daytime distance vision, nighttime distance vision, and indoors distance vision on a scale of 1 to 5, with 1 being very dissatisfied and 5 being very satisfied.
Eligibility Criteria
Criteria
Ages Eligible for Study:
21 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Diagnosed with Cataracts
-
Predicted residual corneal astigmatism between 0.75 and 1.03 Diopters (D)
Exclusion Criteria:
-
Preoperative ocular pathology
-
Planned monovision
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Alcon Call Center for Trial Locations | Fort Worth | Texas | United States | 76134 |
Sponsors and Collaborators
- Alcon Research
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00732030
Other Study ID Numbers:
- M07-005
First Posted:
Aug 11, 2008
Last Update Posted:
Apr 7, 2010
Last Verified:
Mar 1, 2010
Study Results
Participant Flow
| Recruitment Details | Patients were >21 years of age, of any race and either gender. Patients had operable cataracts in at least 1 eye and were able to provide informed consent. Patients were free of systemic diseases affecting ocular health and had a predicted residual corneal astigmatism between 0.75 and 1.03 Diopters (D) by the AcrySof Toric calculator. |
|---|---|
| Pre-assignment Detail | During the preoperative exam, subjects were examined to ensure they met the inclusion/exclusion criteria. Only subjects who signed an informed consent and qualified to be in the study by meeting all inclusion/exclusion criteria were enrolled. |
| Arm/Group Title | AcrySof Toric T3 |
|---|---|
| Arm/Group Description | Each enrolled eye receives AcrySof Toric SN60T3 IOL |
| Period Title: Overall Study | |
| STARTED | 26 |
| COMPLETED | 24 |
| NOT COMPLETED | 2 |
Baseline Characteristics
| Arm/Group Title | AcrySof Toric T3 |
|---|---|
| Arm/Group Description | Each enrolled eye receives AcrySof Toric SN60T3 IOL |
| Overall Participants | 26 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
7
26.9%
|
| >=65 years |
19
73.1%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
16
61.5%
|
| Male |
10
38.5%
|
Outcome Measures
| Title | Uncorrected Distance Visual Acuity |
|---|---|
| Description | Uncorrected Distance Visual Acuity at month 6 measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". It is a unit of measure for visual acuity (VA). |
| Time Frame | 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data was collected for 29 eyes in 24 patients. |
| Arm/Group Title | AcrySof Toric T3 |
|---|---|
| Arm/Group Description | Each enrolled eye receives AcrySof Toric SN60T3 IOL |
| Measure Participants | 24 |
| Mean (Standard Deviation) [logMAR] |
0.09
(0.14)
|
| Title | Best Corrected Distance Visual Acuity |
|---|---|
| Description | Best Corrected Distance Visual Acuity at month 6 measured in LogMAR. LogMAR is the "logarithm of the minimum angle of resolution". It is a unit of measure for visual acuity (VA). |
| Time Frame | 6 Months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data was collected for 29 eyes in 24 patients. |
| Arm/Group Title | AcrySof Toric T3 |
|---|---|
| Arm/Group Description | Each enrolled eye receives AcrySof Toric SN60T3 IOL |
| Measure Participants | 24 |
| Mean (Standard Deviation) [logMAR] |
0.02
(0.09)
|
| Title | Residual Refractive Cylinder |
|---|---|
| Description | Residual Refractive Cylinder at month 6 measured in diopters (D). |
| Time Frame | 6 Month |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | AcrySof Toric T3 |
|---|---|
| Arm/Group Description | Each enrolled eye receives AcrySof Toric SN60T3 IOL |
| Measure Participants | 24 |
| Mean (Standard Deviation) [Diopters] |
0.4
(0.4)
|
| Title | Patient Satisfaction Survey |
|---|---|
| Description | Satisfaction for daytime distance vision, nighttime distance vision, and indoors distance vision on a scale of 1 to 5, with 1 being very dissatisfied and 5 being very satisfied. |
| Time Frame | 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | AcrySof Toric T3 |
|---|---|
| Arm/Group Description | Each enrolled eye receives AcrySof Toric SN60T3 IOL |
| Measure Participants | 24 |
| Daytime Distance Vision |
4.6
(0.6)
|
| Nighttime Distance Vision |
4.4
(0.7)
|
| Indoors Distance Vision |
4.6
(0.7)
|
Adverse Events
| Time Frame | Surgical visit through 6 month postoperative visit. | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | AcrySof Toric T3 | |
| Arm/Group Description | Each enrolled eye receives AcrySof Toric SN60T3 IOL | |
All Cause Mortality |
||
| AcrySof Toric T3 | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| AcrySof Toric T3 | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/24 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| AcrySof Toric T3 | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/24 (0%) | |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
No paper that incorporates Sponsor Confidential Information will be submitted for publication without Sponsor's prior written agreement.
Results Point of Contact
| Name/Title | Alcon Clinical |
|---|---|
| Organization | Alcon Research, Ltd. |
| Phone | 888.451.3937; 817.568.6725 |
| medinfo@alconlabs.com |
Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00732030
Other Study ID Numbers:
- M07-005
First Posted:
Aug 11, 2008
Last Update Posted:
Apr 7, 2010
Last Verified:
Mar 1, 2010