Trial Outcomes & Findings for Cataract Refractive Suite Study (NCT NCT02974140)

Results Overview

Manifest refraction spherical equivalent (MRSE) was calculated as follows: sphere + 1/2 cylinder. The sphere and cylinder values were from the manifest refraction assessment. Manifest refraction was assessed at 4 meters under photopic lighting conditions using a phoropter. Due to early termination of the study and limited sample size, a statistical inference test was not carried out as planned.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

39 participants

Primary outcome timeframe

Day 20-40 from second implantation

Results posted on

2018-09-14

Participant Flow

Subjects were recruited from 3 investigative sites located in the United States.

This reporting group includes all enrolled subjects (39).

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	All Study Subjects Cataract extraction surgery with either Cataract Refractive Suite (CRS) or manual technique in the study eye, defined as the eye with the worst preoperative corrected distance visual acuity (CDVA), with the alternate procedure in the fellow eye
Overall Study STARTED	39 78
Overall Study CRS (Left or Right Eye)	38 38
Overall Study Manual (Fellow Eye)	38 38
Overall Study COMPLETED	0 0
Overall Study NOT COMPLETED	39 78

Reasons for withdrawal

Reasons for withdrawal
Measure	All Study Subjects Cataract extraction surgery with either Cataract Refractive Suite (CRS) or manual technique in the study eye, defined as the eye with the worst preoperative corrected distance visual acuity (CDVA), with the alternate procedure in the fellow eye
Overall Study Adverse Event	2
Overall Study Lost to Follow-up	1
Overall Study Study Terminated by Sponsor	36

Baseline Characteristics

Cataract Refractive Suite Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Subjects n=39 Participants Cataract extraction surgery with either CRS or manual technique in the study eye, defined as the eye with the worst preoperative corrected distance visual acuity (CDVA), with the alternate procedure in the fellow eye
Age, Continuous	67.7 years STANDARD_DEVIATION 7.8 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	38 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 20-40 from second implantation

Population: Full Analysis Set with data available

Manifest refraction spherical equivalent (MRSE) was calculated as follows: sphere + 1/2 cylinder. The sphere and cylinder values were from the manifest refraction assessment. Manifest refraction was assessed at 4 meters under photopic lighting conditions using a phoropter. Due to early termination of the study and limited sample size, a statistical inference test was not carried out as planned.

Outcome measures

Outcome measures
Measure	Suite n=36 Eyes Cataract surgery using Cataract Refractive Suite	Manual n=36 Eyes Cataract surgery using standard manual technique
Percentage of Eyes With Manifest Refraction Spherical Equivalent (MRSE) Within 0.5 Diopter (D) of Predicted Postoperative Spherical Equivalent at Month 1	80.6 percentage of eyes	69.4 percentage of eyes

SECONDARY outcome

Timeframe: Day 0 (operative day), each eye

Population: Full Analysis Set with data available

Cumulative Dissipated Energy (CDE) represents the energy dissipated of the ultrasound tip and infusion sleeve at the incision point during the removal of cataractous lens. CDE was reported on the Vision System interface and measured in percent-seconds. A lower CDE indicates that less energy was expended in the eye. Due to early termination of the study and limited sample size, a statistical inference test was not carried out as planned.

Outcome measures

Outcome measures
Measure	Suite n=37 Eyes Cataract surgery using Cataract Refractive Suite	Manual n=38 Eyes Cataract surgery using standard manual technique
Cumulative Dissipated Energy (CDE)	3.396 percent-seconds Standard Deviation 2.4620	4.032 percent-seconds Standard Deviation 2.6022

SECONDARY outcome

Timeframe: Day 0 (operative day), each eye

Population: Full Analysis Set with data available

Aspiration fluid (amount of fluid used during the removal of the cataractous lens) was measured in milliliters (ml). A lower value indicates less fluid used during the procedure. Due to early termination of the study and limited sample size, a statistical inference test was not carried out as planned.

Outcome measures

Outcome measures
Measure	Suite n=37 Eyes Cataract surgery using Cataract Refractive Suite	Manual n=38 Eyes Cataract surgery using standard manual technique
Estimated Aspiration Fluid Used During Surgery	58.6 ml Standard Deviation 16.48	54.0 ml Standard Deviation 11.57

SECONDARY outcome

Timeframe: Day 0 (operative day), each eye

Population: Full Analysis Set with available data

Phaco aspiration time (the average time the surgeon took to complete the phacoemulsification) was measured in seconds. A lower value indicates that the surgeon spent less time aspirating fluid and material from the eye during surgery. Due to early termination of the study and limited sample size, a statistical inference test was not carried out as planned.

Outcome measures

Outcome measures
Measure	Suite n=37 Eyes Cataract surgery using Cataract Refractive Suite	Manual n=38 Eyes Cataract surgery using standard manual technique
Phaco Aspiration Time Spent During Surgery	197.9 seconds Standard Deviation 77.06	173.3 seconds Standard Deviation 57.89

Adverse Events

Suite (Ocular)

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Manual (Ocular)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Nonocular

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Suite (Ocular) n=38 participants at risk Eyes for which the LenSx was activated and a laser cut was initiated	Manual (Ocular) n=38 participants at risk Eyes for which the incision was initiated using standard manual techniques	Nonocular n=39 participants at risk Subjects for which cataract surgery was conducted in one or both eyes
Eye disorders Retinal Tear	2.6% 1/38 • Surgery through study completion, an average of 1 month. 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 medical device. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. "At risk" population for ocular AEs is reported in units of eyes. Two subjects had only 1 eye treated (39 overall subjects, 38 eyes in each group).	0.00% 0/38 • Surgery through study completion, an average of 1 month. 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 medical device. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. "At risk" population for ocular AEs is reported in units of eyes. Two subjects had only 1 eye treated (39 overall subjects, 38 eyes in each group).	0.00% 0/39 • Surgery through study completion, an average of 1 month. 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 medical device. AEs were obtained through solicited and spontaneous comments from subjects and observations by the Investigator. "At risk" population for ocular AEs is reported in units of eyes. Two subjects had only 1 eye treated (39 overall subjects, 38 eyes in each group).

Other adverse events

Adverse event data not reported

Additional Information

Sr. Global Brand Medical Affairs Lead, CDMA Surgical

Alcon, A Novartis Division

Phone: 1-888-451-3937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Publication restrictions are in place

Restriction type: OTHER