Visual Function After Bilateral Implantation of AcrySof® Toric
This study has been completed.
Sponsor:
Alcon Research
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00758550
First received: September 23, 2008
Last updated: March 4, 2010
Last verified: March 2010
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Results First Received: August 13, 2009
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment |
| Condition: |
Visual Function |
| Interventions: |
Device: AcrySof® Toric IOL Device: AcrySof Natural |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| 60 cataract patients were enrolled into the study |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| Randomized |
Reporting Groups
| Description | |
|---|---|
| AcrySof Toric IOL | AcrySof Toric Intraocular Lens |
| AcrySof Natural IOL | AcrySof Natural Intraocular Lens |
Participant Flow: Overall Study
| AcrySof Toric IOL | AcrySof Natural IOL | |
|---|---|---|
| STARTED | 30 | 30 |
| COMPLETED | 30 | 30 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| AcrySof Toric IOL | AcrySof Toric Intraocular Lens |
| AcrySof Natural IOL | AcrySof Natural Intraocular Lens |
| Total | Total of all reporting groups |
Baseline Measures
| AcrySof Toric IOL | AcrySof Natural IOL | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
30 | 30 | 60 |
|
Age
[units: participants] |
|||
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 12 | 15 | 27 |
| >=65 years | 18 | 15 | 33 |
|
Gender
[units: participants] |
|||
| Female | 17 | 16 | 33 |
| Male | 13 | 14 | 27 |
Outcome Measures
| 1. Primary: | Uncorrected Visual Acuity (UCVA) [ Time Frame: 6 Months after surgery ] |
Hide Outcome Measure 1| Measure Type | Primary |
|---|---|
| Measure Title | Uncorrected Visual Acuity (UCVA) |
| Measure Description | Uncorrected Visual Acuity (UCVA) from surgery measured in logMAR. LogMAR is the “logarithm of the minimum angle of resolution”. A lower logMAR value indicates better visual acuity. |
| Time Frame | 6 Months after surgery |
| Safety Issue | Yes |
Population Description
| Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate. |
|---|
| No text entered. |
Reporting Groups
| Description | |
|---|---|
| AcrySof Toric IOL | AcrySof Toric Intraocular Lens |
| AcrySof Natural IOL | AcrySof Natural Intraocular Lens |
Measured Values
| AcrySof Toric IOL | AcrySof Natural IOL | |
|---|---|---|
|
Number of Participants Analyzed
[units: participants] |
30 | 30 |
|
Uncorrected Visual Acuity (UCVA)
[units: logMAR] Mean ± Standard Deviation |
0.06 ± 0.14 | 0.14 ± 0.11 |
No statistical analysis provided for Uncorrected Visual Acuity (UCVA)
| 2. Secondary: | Questionnaire Results [ Time Frame: 6 Months ] |
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| Principal Investigators are NOT employed by the organization sponsoring the study. |
| There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. |
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| No text entered. |
Results Point of Contact:
Name/Title: Alcon Clinical
Organization: Alcon Research, Ltd.
phone: 888.451.3937; 817.568.6725
e-mail: medinfo@alconlabs.com
Organization: Alcon Research, Ltd.
phone: 888.451.3937; 817.568.6725
e-mail: medinfo@alconlabs.com
No publications provided
| Responsible Party: | Benny Li, Scientific Clinical Affairs Manager, Alcon Research Ltd. |
| ClinicalTrials.gov Identifier: | NCT00758550 History of Changes |
| Other Study ID Numbers: | CM-06-17 |
| Study First Received: | September 23, 2008 |
| Results First Received: | August 13, 2009 |
| Last Updated: | March 4, 2010 |
| Health Authority: | China: Ethics Committee |