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Clinical Investigation of Corneal Incision Size After Intraocular Lens (IOL) Implantation

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ClinicalTrials.gov Identifier: NCT02826421
Recruitment Status : Completed
First Posted : July 11, 2016
Results First Posted : July 28, 2017
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Cataracts
Interventions Device: UltraSert Preloaded Delivery System
Device: iTec Preloaded Delivery System
Device: iSert Preloaded Delivery System
Device: Monarch III D Manual IOL Delivery System
Enrollment 114
Recruitment Details Subjects were recruited from 4 study centers located in Spain and 2 study centers located in France.
Pre-assignment Details Of the 114 enrolled, 2 subjects did not meet inclusion/exclusion criteria, and 3 subjects were excluded prior to randomization for “other” reasons (ie, the maximum number of randomized subjects was reached). This reporting group includes all randomized subjects (109).
Arm/Group Title UltraSert iTec iSert Monarch III D
Hide Arm/Group Description Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery Manually loaded IOL delivered via a 2.4 mm clear corneal incision during cataract surgery
Period Title: Overall Study
Started 22 29 28 30
Treated 19 26 26 28
Completed 19 26 26 28
Not Completed 3 3 2 2
Reason Not Completed
Adverse Event             1             0             0             1
Withdrawal by Subject             1             3             1             1
Reason not given             1             0             1             0
Arm/Group Title UltraSert iTec iSert Monarch III D Total
Hide Arm/Group Description Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery Manually loaded IOL delivered via a 2.4 mm clear corneal incision during cataract surgery Total of all reporting groups
Overall Number of Baseline Participants 19 26 26 28 99
Hide Baseline Analysis Population Description
This analysis population includes all randomized subjects whose cataract surgery procedure was completed (Full Analysis Set).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 26 participants 26 participants 28 participants 99 participants
71.4  (8.71) 70.7  (8.31) 73.0  (7.27) 72.5  (7.10) 71.9  (7.73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 26 participants 26 participants 28 participants 99 participants
Female
14
  73.7%
13
  50.0%
14
  53.8%
17
  60.7%
58
  58.6%
Male
5
  26.3%
13
  50.0%
12
  46.2%
11
  39.3%
41
  41.4%
1.Primary Outcome
Title Mean Corneal Incision Size After IOL Implantation (UltraSert, iTec, and iSert)
Hide Description Post-IOL implantation corneal incision size was measured directly after IOL implantation and reported in millimeters (mm). Minimizing enlargement of incision size during cataract surgery results in less postoperative inflammation, less surgically-induced astigmatism, and more rapid visual and wound rehabilitation. This endpoint was prespecified for the UltraSert, iTec, and iSert preloaded delivery systems. Only one eye (study eye) contributed to the analysis.
Time Frame Day 0, operative day
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title UltraSert iTec iSert
Hide Arm/Group Description:
Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
Overall Number of Participants Analyzed 19 26 26
Mean (Standard Error)
Unit of Measure: mm
2.35  (0.019) 2.47  (0.016) 2.54  (0.019)
2.Secondary Outcome
Title Mean Corneal Incision Size After IOL Implantation (UltraSert and Monarch III D)
Hide Description Post-IOL implantation corneal incision size was measured directly after IOL implantation and reported in millimeters (mm). Minimizing enlargement of incision size during cataract surgery results in less postoperative inflammation, less surgically-induced astigmatism, and more rapid visual and wound rehabilitation. This endpoint was prespecified for the UltraSert preloaded delivery system and the Monarch III D delivery system. Only one eye (study eye) contributed to the analysis.
Time Frame Day 0, operative day
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title UltraSert Monarch III D
Hide Arm/Group Description:
Preloaded IOL delivered via a 2.2 mm clear corneal incision during cataract surgery
Manually loaded IOL delivered via a 2.4 mm clear corneal incision during cataract surgery
Overall Number of Participants Analyzed 19 28
Mean (Standard Error)
Unit of Measure: mm
2.35  (0.019) 2.49  (0.011)
Time Frame Adverse events (AEs) were collected from time of consent for the duration of a subject’s participation in the study (up to 31 days). AEs are reported as pretreatment and treatment-emergent.
Adverse Event Reporting Description An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the medical device. Ocular adverse events are presented for both study eye and non-study eye combined.
 
Arm/Group Title Pretreatment UltraSert iTec iSert Monarch III D
Hide Arm/Group Description All subjects who consented to participate in the study prior to initiation of study treatment All subjects treated with UltraSert All subjects treated with iTec All subjects treated with iSert All subjects treated with Monarch III D
All-Cause Mortality
Pretreatment UltraSert iTec iSert Monarch III D
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/114 (0.00%)   0/19 (0.00%)   0/26 (0.00%)   0/26 (0.00%)   0/28 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Pretreatment UltraSert iTec iSert Monarch III D
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/114 (0.88%)   0/19 (0.00%)   1/26 (3.85%)   0/26 (0.00%)   0/28 (0.00%) 
Infections and infestations           
Gastroenteritis  1/114 (0.88%)  0/19 (0.00%)  0/26 (0.00%)  0/26 (0.00%)  0/28 (0.00%) 
Injury, poisoning and procedural complications           
Cataract operation complication  0/114 (0.00%)  0/19 (0.00%)  1/26 (3.85%)  0/26 (0.00%)  0/28 (0.00%) 
Surgical procedure repeated  0/114 (0.00%)  0/19 (0.00%)  1/26 (3.85%)  0/26 (0.00%)  0/28 (0.00%) 
1
Term from vocabulary, MedDRA (19.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pretreatment UltraSert iTec iSert Monarch III D
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/114 (0.00%)   0/19 (0.00%)   0/26 (0.00%)   0/26 (0.00%)   0/28 (0.00%) 
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
Name/Title: Sr Global Brand Medical Affairs Lead, CDMA Surgical
Organization: Alcon, A Novartis Division
Phone: 1-888-451-3937
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT02826421     History of Changes
Other Study ID Numbers: ILN296-P001
First Submitted: July 5, 2016
First Posted: July 11, 2016
Results First Submitted: June 30, 2017
Results First Posted: July 28, 2017
Last Update Posted: July 2, 2018