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

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ClinicalTrials.gov Identifier: NCT01161771
Recruitment Status : Completed
First Posted : July 14, 2010
Results First Posted : July 26, 2012
Last Update Posted : July 26, 2012
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Condition Dry Eye
Intervention Procedure: Cataract Surgery and Limbal relaxing incision
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Patients With Cataract and Corneal Astigmatism
Hide Arm/Group Description Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)
Period Title: Overall Study
Started 32
Completed 32
Not Completed 0
Arm/Group Title Patients With Cataract and Corneal Astigmatism
Hide Arm/Group Description Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)
Overall Number of Baseline Participants 32
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 32 participants
68.29
(51.64 to 83.84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
Female
21
  65.6%
Male
11
  34.4%
1.Primary Outcome
Title The Percentage of Subjects at Month 3 With Corneal Sensitivity < 50 Millimeters (mm) at Any of the Locations Measured
Hide Description The percentage of subjects at month 3 with corneal sensitivity < 50 mm at any of the locations measured. Corneal sensitivity is evaluated by using a nylon filament to measure the capability of the cornea (clear front portion of the eye) to respond to touch. The longest filament length at which a minimum of the 3 out of 5 stimulus applications produce a positive response from the subject was the corneal touch threshold (sensitivity). Measurements were taken at 5 different locations in each cornea.
Time Frame Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects enrolled who met the inclusion criteria of having 2 limbal relaxing incisions (LRIs) during cataract extraction. Nine (9) subjects only had 1 LRI.
Arm/Group Title Patients With Cataract and Corneal Astigmatism
Hide Arm/Group Description:
Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)
Overall Number of Participants Analyzed 23
Measure Type: Number
Unit of Measure: Percentage of Subjects
Area 1 (Center) at Month 3 13
Area 2 (Center of LRI 1) at Month 3 13
Area 3 (Center of LRI 2) at Month 3 21.7
Area 4 (90 degrees from LRI 1) at Month 3 13
Area 5 (90 degrees from LRI 2) at Month 3 8.7
2.Secondary Outcome
Title Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score at Month 3
Hide Description Change from baseline in OSDI total score at month 3. The OSDI is a 12-question survey for subjects to document their dry eye disease symptoms. The OSDI consists of a 5-point scale (0=none of the time and 4 = all of the time), with higher scores representing greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement.
Time Frame Baseline, Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects enrolled who met the inclusion criteria of having 2 limbal relaxing incisions (LRIs) during cataract extraction. Nine (9) subjects only had 1 LRI.
Arm/Group Title Patients With Cataract and Corneal Astigmatism
Hide Arm/Group Description:
Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)
Overall Number of Participants Analyzed 23
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Baseline 15.739  (8.368)
Change from Baseline at Month 3 -9.826  (7.912)
3.Secondary Outcome
Title Change From Baseline in Corneal Staining at Month 3
Hide Description Change from baseline in corneal staining at month 3. The cornea is the transparent front part of the eye which covers the iris and pupil. Corneal staining following administration of fluorescein dye in the eye is graded using a 6-point scale (0= no staining, 5 = severe staining) over 5 areas of the clear central part of the eye for a minimum score of 0 and a maximum score of 25. The higher the grade score, the worse the dry eye condition. A positive number change from baseline represents an increase in corneal staining (worsening of dry eye).
Time Frame Baseline, Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects enrolled who met the inclusion criteria of having 2 limbal relaxing incisions (LRIs) during cataract extraction. Nine (9) subjects only had 1 LRI.
Arm/Group Title Patients With Cataract and Corneal Astigmatism
Hide Arm/Group Description:
Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)
Overall Number of Participants Analyzed 23
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Baseline 0.652  (1.668)
Change from Baseline at Month 3 0.261  (2.158)
4.Secondary Outcome
Title Change From Baseline in Conjunctival Staining at Month 3
Hide Description Change from baseline in conjunctival staining severity score at month 3. The conjunctiva is the clear membrane covering the white surface of the eye. Conjunctival staining following ocular administration of lissamine green dye was graded using a 6-point scale (0= no staining, 5= severe staining) over 6 areas of the white part of the eye for a minimum score of 0 and a maximum score of 30. The higher the score, the worse the dry eye condition. A negative number change from baseline represents a decrease in the severity of conjunctival staining (improvement)
Time Frame Baseline, Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects enrolled who met the inclusion criteria of having 2 limbal incisions (LRIs) during cataract extraction. Nine (9) subjects only had 1 LRI.
Arm/Group Title Patients With Cataract and Corneal Astigmatism
Hide Arm/Group Description:
Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)
Overall Number of Participants Analyzed 23
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Baseline 1.087  (2.557)
Change from Baseline at Month 3 -0.174  (2.949)
5.Secondary Outcome
Title Change From Baseline in Tear Break-Up Time at Month 3
Hide Description Change from baseline in tear break-up time (TBUT) at month 3. TBUT is the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film. A negative number change from baseline indicates a decrease in TBUT (worsening).
Time Frame Baseline, Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects enrolled who met the inclusion criteria of having 2 limbal relaxing incisions (LRIs) during cataract extraction. Nine (9) subjects only had 1 LRI.
Arm/Group Title Patients With Cataract and Corneal Astigmatism
Hide Arm/Group Description:
Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)
Overall Number of Participants Analyzed 23
Mean (Standard Deviation)
Unit of Measure: Seconds
Baseline 16.4  (12.5)
Change from Baseline at Month 3 -3.71 [1]   (NA)
[1]
Mean calculated without standard deviation. No other measure of dispersion was calculated.
6.Secondary Outcome
Title Change From Baseline in Schirmer's Test at Month 3
Hide Description Change from baseline in Schirmer’s Test result at month 3. The Schirmer’s Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye. A positive number change from baseline indicates an increase in tears (improvement).
Time Frame Baseline, Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects enrolled who met the inclusion criteria of having 2 limbal relaxing incisions (LRIs) during cataract extraction. Nine (9) subjects only had 1 LRI.
Arm/Group Title Patients With Cataract and Corneal Astigmatism
Hide Arm/Group Description:
Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)
Overall Number of Participants Analyzed 23
Mean (Standard Deviation)
Unit of Measure: Millimeters of Tears
Baseline 11.091  (5.163)
Change from Baseline at Month 3 0.909  (5.74)
Time Frame [Not Specified]
Adverse Event Reporting Description Serious Adverse Events and Adverse Events were not collected.
 
Arm/Group Title Patients With Cataract and Corneal Astigmatism
Hide Arm/Group Description Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)
All-Cause Mortality
Patients With Cataract and Corneal Astigmatism
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Patients With Cataract and Corneal Astigmatism
Affected / at Risk (%)
Total   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Patients With Cataract and Corneal Astigmatism
Affected / at Risk (%)
Total   0/0 
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.
A 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 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo
Results Point of Contact
Name/Title: Vice President, Global Medical Affairs
Organization: Allergan, Inc.
Phone: 714-246-4500
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01161771     History of Changes
Other Study ID Numbers: MA-RES-09-004
First Submitted: July 6, 2010
First Posted: July 14, 2010
Results First Submitted: December 13, 2011
Results First Posted: July 26, 2012
Last Update Posted: July 26, 2012