Effects of Cataract Extraction Surgery and Limbal Relaxing Incision on Corneal Sensation and Dry Eye

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01161771
First received: July 6, 2010
Last updated: July 17, 2012
Last verified: July 2012
Results First Received: December 13, 2011  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Dry Eye
Intervention: Procedure: Cataract Surgery and Limbal relaxing incision

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Patients With Cataract and Corneal Astigmatism Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)

Participant Flow:   Overall Study
    Patients With Cataract and Corneal Astigmatism  
STARTED     32  
COMPLETED     32  
NOT COMPLETED     0  



  Baseline Characteristics
  Hide Baseline Characteristics

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
Patients With Cataract and Corneal Astigmatism Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)

Baseline Measures
    Patients With Cataract and Corneal Astigmatism  
Number of Participants  
[units: participants]
  32  
Age  
[units: years]
Median ( Full Range )
  68.29  
  ( 51.64 to 83.84 )  
Gender  
[units: participants]
 
Female     21  
Male     11  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Percentage of Subjects at Month 3 With Corneal Sensitivity < 50 Millimeters (mm) at Any of the Locations Measured   [ Time Frame: Month 3 ]

2.  Secondary:   Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score at Month 3   [ Time Frame: Baseline, Month 3 ]

3.  Secondary:   Change From Baseline in Corneal Staining at Month 3   [ Time Frame: Baseline, Month 3 ]

4.  Secondary:   Change From Baseline in Conjunctival Staining at Month 3   [ Time Frame: Baseline, Month 3 ]

5.  Secondary:   Change From Baseline in Tear Break-Up Time at Month 3   [ Time Frame: Baseline, Month 3 ]

6.  Secondary:   Change From Baseline in Schirmer's Test at Month 3   [ Time Frame: Baseline, Month 3 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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: Vice President, Global Medical Affairs
Organization: Allergan, Inc.
phone: 714-246-4500
e-mail: clinicaltrials@allergan.com


No publications provided


Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01161771     History of Changes
Other Study ID Numbers: MA-RES-09-004
Study First Received: July 6, 2010
Results First Received: December 13, 2011
Last Updated: July 17, 2012
Health Authority: United States: Institutional Review Board