Trial Outcomes & Findings for Capsular Tension Rings in Intraocular Lens Rotation (NCT NCT04436198)

Last Updated: 2024-08-19

Results Overview

The eye(s) enrolled in the study will be dilated and slit lamp photography taken using retroillumination. The capsular tension ring will not be visible in the slit lamp photos or during the eye exams. The patient will be blinded as to which eye is in the treatment or control group. The slit lamp photos will be de-identified and used to determine the axis of the toric IOL by evaluators blinded to the patient identity and control/treatment group. The toric axis will be identified using either ImageJ (NIH) or Adobe Illustrator by measuring the angle between a straight line drawn across the toric axis markers and a straight line at the horizontal axis (0 degrees).

Recruitment status

TERMINATED

Study phase

Target enrollment

12 participants

Primary outcome timeframe

6 months

Results posted on

2024-08-19

Participant Flow

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	Treatment Group: Toric IOL Plus Capsular Tension Ring MORCHER® EYEJET® CTR Types 14, 14A, and 14C: Intervention. Toric IOL + CTR. Whether the subject receives 14, 14A, or 14C is an either or scenario depending on the eye's axial length and is a single intervention: Axial length \> 28.0 mm: CTR model 14A Axial length 24.0-28.0 mm: CTR model 14C Axial length \< 24.0 mm: CTR model 14 Lens Selection: The patients will undergo standard of care preoperative measurements and planning. The surgeon will evaluate preoperative measurements and use lens calculations, as well as a discussion with the patient, to identify whether a toric lens will be used and to determine the IOL power, cylinder, and target axis (standard of care). Preoperative measurements will be taken using IOL-Master 700, with the addition of the Pentacam and automatic keratometry as needed (standard of care). The toric lens used will be the TECNIS IOL. It will be used on label (standard of care).	Control Group: Toric IOL Only Toric IOL Only: Control. Toric IOL only. Standard of care cataract surgery without placement of a capsular tension ring. Lens Selection: The patients will undergo standard of care preoperative measurements and planning. The surgeon will evaluate preoperative measurements and use lens calculations, as well as a discussion with the patient, to identify whether a toric lens will be used and to determine the IOL power, cylinder, and target axis (standard of care). Preoperative measurements will be taken using IOL-Master 700, with the addition of the Pentacam and automatic keratometry as needed (standard of care). The toric lens used will be the TECNIS IOL. It will be used on label (standard of care).
Overall Study STARTED	7 7	6 6
Overall Study COMPLETED	5 5	3 3
Overall Study NOT COMPLETED	2 2	3 3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

As this study measured eyes not subjects, one subject had an eye in control and the other eye in treatment. As such, row population is larger than overall population as one subject is reported in both rows.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Group: Toric IOL Plus Capsular Tension Ring n=7 eyes MORCHER® EYEJET® CTR Types 14, 14A, and 14C: Intervention. Toric IOL + CTR. Whether the subject receives 14, 14A, or 14C is an either or scenario depending on the eye's axial length and is a single intervention: Axial length \> 28.0 mm: CTR model 14A Axial length 24.0-28.0 mm: CTR model 14C Axial length \< 24.0 mm: CTR model 14 Lens Selection: The patients will undergo standard of care preoperative measurements and planning. The surgeon will evaluate preoperative measurements and use lens calculations, as well as a discussion with the patient, to identify whether a toric lens will be used and to determine the IOL power, cylinder, and target axis (standard of care). Preoperative measurements will be taken using IOL-Master 700, with the addition of the Pentacam and automatic keratometry as needed (standard of care). The toric lens used will be the TECNIS IOL. It will be used on label (standard of care).	Control Group: Toric IOL Only n=6 eyes Toric IOL Only: Control. Toric IOL only. Standard of care cataract surgery without placement of a capsular tension ring. Lens Selection: The patients will undergo standard of care preoperative measurements and planning. The surgeon will evaluate preoperative measurements and use lens calculations, as well as a discussion with the patient, to identify whether a toric lens will be used and to determine the IOL power, cylinder, and target axis (standard of care). Preoperative measurements will be taken using IOL-Master 700, with the addition of the Pentacam and automatic keratometry as needed (standard of care). The toric lens used will be the TECNIS IOL. It will be used on label (standard of care).	Total n=13 eyes Total of all reporting groups
Age, Categorical <=18 years	0 eyes n=32 eyes • As this study measured eyes not subjects, one subject had an eye in control and the other eye in treatment. As such, row population is larger than overall population as one subject is reported in both rows.	0 eyes n=16 eyes • As this study measured eyes not subjects, one subject had an eye in control and the other eye in treatment. As such, row population is larger than overall population as one subject is reported in both rows.	0 eyes n=48 eyes • As this study measured eyes not subjects, one subject had an eye in control and the other eye in treatment. As such, row population is larger than overall population as one subject is reported in both rows.
Age, Categorical Between 18 and 65 years	0 eyes n=32 eyes • As this study measured eyes not subjects, one subject had an eye in control and the other eye in treatment. As such, row population is larger than overall population as one subject is reported in both rows.	1 eyes n=16 eyes • As this study measured eyes not subjects, one subject had an eye in control and the other eye in treatment. As such, row population is larger than overall population as one subject is reported in both rows.	1 eyes n=48 eyes • As this study measured eyes not subjects, one subject had an eye in control and the other eye in treatment. As such, row population is larger than overall population as one subject is reported in both rows.
Age, Categorical >=65 years	7 eyes n=32 eyes • As this study measured eyes not subjects, one subject had an eye in control and the other eye in treatment. As such, row population is larger than overall population as one subject is reported in both rows.	5 eyes n=16 eyes • As this study measured eyes not subjects, one subject had an eye in control and the other eye in treatment. As such, row population is larger than overall population as one subject is reported in both rows.	12 eyes n=48 eyes • As this study measured eyes not subjects, one subject had an eye in control and the other eye in treatment. As such, row population is larger than overall population as one subject is reported in both rows.
Sex: Female, Male Female	5 eyes n=32 eyes • As this study measured eyes not subjects, one subject had an eye in control and the other eye in treatment. As such, row population is larger than overall population as one subject is reported in both rows.	3 eyes n=16 eyes • As this study measured eyes not subjects, one subject had an eye in control and the other eye in treatment. As such, row population is larger than overall population as one subject is reported in both rows.	8 eyes n=48 eyes • As this study measured eyes not subjects, one subject had an eye in control and the other eye in treatment. As such, row population is larger than overall population as one subject is reported in both rows.
Sex: Female, Male Male	2 eyes n=32 eyes • As this study measured eyes not subjects, one subject had an eye in control and the other eye in treatment. As such, row population is larger than overall population as one subject is reported in both rows.	3 eyes n=16 eyes • As this study measured eyes not subjects, one subject had an eye in control and the other eye in treatment. As such, row population is larger than overall population as one subject is reported in both rows.	5 eyes n=48 eyes • As this study measured eyes not subjects, one subject had an eye in control and the other eye in treatment. As such, row population is larger than overall population as one subject is reported in both rows.
Race (NIH/OMB) American Indian or Alaska Native	0 eyes n=32 eyes • As this study measured eyes not subjects, one subject had an eye in control and the other eye in treatment. As such, row population is larger than overall population as one subject is reported in both rows.	0 eyes n=16 eyes • As this study measured eyes not subjects, one subject had an eye in control and the other eye in treatment. As such, row population is larger than overall population as one subject is reported in both rows.	0 eyes n=48 eyes • As this study measured eyes not subjects, one subject had an eye in control and the other eye in treatment. As such, row population is larger than overall population as one subject is reported in both rows.
Race (NIH/OMB) Asian	1 eyes n=32 eyes • As this study measured eyes not subjects, one subject had an eye in control and the other eye in treatment. As such, row population is larger than overall population as one subject is reported in both rows.	1 eyes n=16 eyes • As this study measured eyes not subjects, one subject had an eye in control and the other eye in treatment. As such, row population is larger than overall population as one subject is reported in both rows.	2 eyes n=48 eyes • As this study measured eyes not subjects, one subject had an eye in control and the other eye in treatment. As such, row population is larger than overall population as one subject is reported in both rows.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 eyes n=32 eyes • As this study measured eyes not subjects, one subject had an eye in control and the other eye in treatment. As such, row population is larger than overall population as one subject is reported in both rows.	1 eyes n=16 eyes • As this study measured eyes not subjects, one subject had an eye in control and the other eye in treatment. As such, row population is larger than overall population as one subject is reported in both rows.	1 eyes n=48 eyes • As this study measured eyes not subjects, one subject had an eye in control and the other eye in treatment. As such, row population is larger than overall population as one subject is reported in both rows.
Race (NIH/OMB) Black or African American	1 eyes n=32 eyes • As this study measured eyes not subjects, one subject had an eye in control and the other eye in treatment. As such, row population is larger than overall population as one subject is reported in both rows.	0 eyes n=16 eyes • As this study measured eyes not subjects, one subject had an eye in control and the other eye in treatment. As such, row population is larger than overall population as one subject is reported in both rows.	1 eyes n=48 eyes • As this study measured eyes not subjects, one subject had an eye in control and the other eye in treatment. As such, row population is larger than overall population as one subject is reported in both rows.
Race (NIH/OMB) White	4 eyes n=32 eyes • As this study measured eyes not subjects, one subject had an eye in control and the other eye in treatment. As such, row population is larger than overall population as one subject is reported in both rows.	3 eyes n=16 eyes • As this study measured eyes not subjects, one subject had an eye in control and the other eye in treatment. As such, row population is larger than overall population as one subject is reported in both rows.	7 eyes n=48 eyes • As this study measured eyes not subjects, one subject had an eye in control and the other eye in treatment. As such, row population is larger than overall population as one subject is reported in both rows.
Race (NIH/OMB) More than one race	1 eyes n=32 eyes • As this study measured eyes not subjects, one subject had an eye in control and the other eye in treatment. As such, row population is larger than overall population as one subject is reported in both rows.	1 eyes n=16 eyes • As this study measured eyes not subjects, one subject had an eye in control and the other eye in treatment. As such, row population is larger than overall population as one subject is reported in both rows.	2 eyes n=48 eyes • As this study measured eyes not subjects, one subject had an eye in control and the other eye in treatment. As such, row population is larger than overall population as one subject is reported in both rows.
Race (NIH/OMB) Unknown or Not Reported	0 eyes n=32 eyes • As this study measured eyes not subjects, one subject had an eye in control and the other eye in treatment. As such, row population is larger than overall population as one subject is reported in both rows.	0 eyes n=16 eyes • As this study measured eyes not subjects, one subject had an eye in control and the other eye in treatment. As such, row population is larger than overall population as one subject is reported in both rows.	0 eyes n=48 eyes • As this study measured eyes not subjects, one subject had an eye in control and the other eye in treatment. As such, row population is larger than overall population as one subject is reported in both rows.
Region of Enrollment United States	2 eyes n=32 eyes • As this study measured eyes not subjects, one subject had an eye in control and the other eye in treatment. As such, row population is larger than overall population as one subject is reported in both rows.	4 eyes n=16 eyes • As this study measured eyes not subjects, one subject had an eye in control and the other eye in treatment. As such, row population is larger than overall population as one subject is reported in both rows.	6 eyes n=48 eyes • As this study measured eyes not subjects, one subject had an eye in control and the other eye in treatment. As such, row population is larger than overall population as one subject is reported in both rows.

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Treatment Group: Toric IOL Plus Capsular Tension Ring n=5 eyes MORCHER® EYEJET® CTR Types 14, 14A, and 14C: Intervention. Toric IOL + CTR. Whether the subject receives 14, 14A, or 14C is an either or scenario depending on the eye's axial length and is a single intervention: Axial length \> 28.0 mm: CTR model 14A Axial length 24.0-28.0 mm: CTR model 14C Axial length \< 24.0 mm: CTR model 14 Lens Selection: The patients will undergo standard of care preoperative measurements and planning. The surgeon will evaluate preoperative measurements and use lens calculations, as well as a discussion with the patient, to identify whether a toric lens will be used and to determine the IOL power, cylinder, and target axis (standard of care). Preoperative measurements will be taken using IOL-Master 700, with the addition of the Pentacam and automatic keratometry as needed (standard of care). The toric lens used will be the TECNIS IOL. It will be used on label (standard of care).	Control Group: Toric IOL Only n=3 eyes Toric IOL Only: Control. Toric IOL only. Standard of care cataract surgery without placement of a capsular tension ring. Lens Selection: The patients will undergo standard of care preoperative measurements and planning. The surgeon will evaluate preoperative measurements and use lens calculations, as well as a discussion with the patient, to identify whether a toric lens will be used and to determine the IOL power, cylinder, and target axis (standard of care). Preoperative measurements will be taken using IOL-Master 700, with the addition of the Pentacam and automatic keratometry as needed (standard of care). The toric lens used will be the TECNIS IOL. It will be used on label (standard of care).
Degree of Toric Rotation Away From Target Axis in Enrolled Eye/s average difference between intended toric axis (degrees)	5.739 degree of rotation Interval 0.506 to 11.383	3 degree of rotation Interval 2.82 to 15.5173
Degree of Toric Rotation Away From Target Axis in Enrolled Eye/s average difference between intended axis (degrees)	5 degree of rotation Interval 1.0 to 13.0	10 degree of rotation Interval 7.0 to 13.0

Adverse Events

Treatment Group: Toric IOL Plus Capsular Tension Ring

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group: Toric IOL Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Amanda Crawford

Regional Clinical Investigation Program

Phone: 7026533583

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place