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Femtosecond Laser Assisted Cataract Surgery in Intumescent Cataracts

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02403206
Recruitment Status : Completed
First Posted : March 31, 2015
Results First Posted : July 25, 2017
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Alcon Research ( Alcon, a Novartis Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Intumescent Cataract
Interventions Device: Femtosecond laser
Procedure: Continuous Curvilinear Capsulorhexis (CCC)
Enrollment 406
Recruitment Details Subjects were recruited from 14 investigative sites: 1 located in Greece, 4 located in India, 2 located in Mexico, 1 located in the Philippines, 3 located in Romania, and 3 located in the US.
Pre-assignment Details Of the 406 enrolled, 6 subjects were exited as screen failures and 10 withdrew prior to randomization. This reporting group includes all randomized subjects (390).
Arm/Group Title Laser (LSX) Manual (CCC)
Hide Arm/Group Description Femtosecond laser assisted capsulotomy and corneal incision performed during cataract surgery Continuous curvilinear capsulorhexis (CCC) performed during cataract surgery
Period Title: Overall Study
Started 194 196
Treated Prior to Randomization 0 1
Randomized and Treated 188 190
Completed 183 186
Not Completed 11 10
Reason Not Completed
Lost to Follow-up             4             3
Physician Decision             2             0
Withdrawal by Subject             3             3
Reason not given             2             4
Arm/Group Title Laser (LSX) Manual (CCC) Total
Hide Arm/Group Description Femtosecond laser assisted capsulotomy and corneal incision performed during cataract surgery CCC performed during cataract surgery Total of all reporting groups
Overall Number of Baseline Participants 187 189 376
Hide Baseline Analysis Population Description
This analysis population includes subjects who signed an informed consent form, were randomized, and underwent the removal of an intumescent cataract with subsequent IOL implantation (Intent-to-Treat (ITT)).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 187 participants 189 participants 376 participants
64.9  (13.6) 66.4  (11.9) 65.6  (12.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 187 participants 189 participants 376 participants
Female
110
  58.8%
117
  61.9%
227
  60.4%
Male
77
  41.2%
72
  38.1%
149
  39.6%
1.Primary Outcome
Title Percentage of Capsular Tears (Anterior or Posterior) During Surgery
Hide Description A capsular tear is defined as any unintended tear on the anterior or posterior capsule and includes a radial tear that moves peripherally on the anterior capsule during capsulotomy and extends to form a posterior capsular tear during intumescent cataract surgery. An intumescent cataract is defined as a cataract with a pressurized capsular bag. A lower value indicates fewer capsular tears. Only one eye (study eye) contributed to the analysis.
Time Frame Day 0 (operative day)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Analysis Set
Arm/Group Title Laser (LSX) Manual (CCC)
Hide Arm/Group Description:
Femtosecond laser assisted capsulotomy and corneal incision performed during cataract surgery
CCC performed during cataract surgery
Overall Number of Participants Analyzed 187 189
Measure Type: Number
Unit of Measure: percentage of capsular tears
5.3 5.3
2.Secondary Outcome
Title Operating Time in the Eye to Complete Entire Cataract Procedure
Hide Description Operating time in the eye was the time interval (in seconds) from the time the corneal incision was opened to the time the wound was closed. Only one eye (study eye) contributed to the analysis.
Time Frame Day 0 (operative day)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Analysis Set
Arm/Group Title Laser (LSX) Manual (CCC)
Hide Arm/Group Description:
Femtosecond laser assisted capsulotomy and corneal incision performed during cataract surgery
CCC performed during cataract surgery
Overall Number of Participants Analyzed 187 189
Mean (Standard Deviation)
Unit of Measure: seconds
795.0  (354.7) 856.6  (436.3)
Time Frame Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 75 days). AEs are reported as pre-treatment and treatment-emergent.
Adverse Event Reporting Description An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product (test or control article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
 
Arm/Group Title Pretreatment Laser (LSX) Manual (CCC)
Hide Arm/Group Description All subjects who consented to participate in the study prior to initiation of study treatment Subjects who underwent femtosecond laser-assisted cataract surgery Subjects who underwent CCC-assisted cataract surgery
All-Cause Mortality
Pretreatment Laser (LSX) Manual (CCC)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/406 (0.00%)   0/188 (0.00%)   0/191 (0.00%) 
Hide Serious Adverse Events
Pretreatment Laser (LSX) Manual (CCC)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/406 (0.25%)   16/188 (8.51%)   14/191 (7.33%) 
Cardiac disorders       
Myocardial infarction  1  0/406 (0.00%)  1/188 (0.53%)  0/191 (0.00%) 
Eye disorders       
Aphakia  1  0/406 (0.00%)  0/188 (0.00%)  1/191 (0.52%) 
Iridocele  1  0/406 (0.00%)  0/188 (0.00%)  1/191 (0.52%) 
Iris adhesions  1  0/406 (0.00%)  0/188 (0.00%)  1/191 (0.52%) 
Iris atrophy  1  0/406 (0.00%)  0/188 (0.00%)  1/191 (0.52%) 
Posterior capsule rupture  1  0/406 (0.00%)  4/188 (2.13%)  2/191 (1.05%) 
Retinal detachment  1  0/406 (0.00%)  0/188 (0.00%)  1/191 (0.52%) 
Vitreous loss  1  0/406 (0.00%)  2/188 (1.06%)  1/191 (0.52%) 
Injury, poisoning and procedural complications       
Cataract operation complication  1  0/406 (0.00%)  1/188 (0.53%)  0/191 (0.00%) 
Procedural complication  1  1/406 (0.25%)  9/188 (4.79%)  9/191 (4.71%) 
Investigations       
Intraocular pressure increased  1  0/406 (0.00%)  1/188 (0.53%)  0/191 (0.00%) 
Surgical and medical procedures       
Eye operation  1  0/406 (0.00%)  2/188 (1.06%)  0/191 (0.00%) 
Glaucoma surgery  1  0/406 (0.00%)  1/188 (0.53%)  0/191 (0.00%) 
Intraocular lens implant  1  0/406 (0.00%)  0/188 (0.00%)  1/191 (0.52%) 
Retinopexy  1  0/406 (0.00%)  0/188 (0.00%)  1/191 (0.52%) 
Vitrectomy  1  1/406 (0.25%)  3/188 (1.60%)  1/191 (0.52%) 
1
Term from vocabulary, MedDRA (17.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pretreatment Laser (LSX) Manual (CCC)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/406 (0.00%)   46/188 (24.47%)   43/191 (22.51%) 
Eye disorders       
Conjunctival haemorrhage  1  0/406 (0.00%)  11/188 (5.85%)  2/191 (1.05%) 
Corneal disorder  1  0/406 (0.00%)  16/188 (8.51%)  19/191 (9.95%) 
Corneal oedema  1  0/406 (0.00%)  40/188 (21.28%)  39/191 (20.42%) 
Ocular hypertension  1  0/406 (0.00%)  10/188 (5.32%)  3/191 (1.57%) 
1
Term from vocabulary, MedDRA (17.0)
Indicates events were collected by systematic assessment
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.
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Brand Medical Affairs Lead, CDMA Surgical
Organization: Alcon, A Novartis Division
Phone: 1-888-451-3937
EMail: alcon.medinfo@alcon.com
Layout table for additonal information
Responsible Party: Alcon Research ( Alcon, a Novartis Company )
ClinicalTrials.gov Identifier: NCT02403206    
Other Study ID Numbers: CTW860-P001
First Submitted: March 26, 2015
First Posted: March 31, 2015
Results First Submitted: May 30, 2017
Results First Posted: July 25, 2017
Last Update Posted: July 2, 2018