Trial Outcomes & Findings for Clinical Performance of a Phakic Intraocular Lens (IOL) (NCT NCT03499821)

NCT ID: NCT03499821

Last Updated: 2025-03-07

Results Overview

Number of Eyes with Monocular Uncorrected Near Visual Acuity of 20/40 or better at 40 cm six months after implantation

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 41 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2025-03-07

Participant Flow

A total of 41 subjects were screened in the study. Six did not meet eligibility and 35 subjects were treated at 6 clinical sites in Europe (5 sites in Spain and 1 site in Belgium). The first enrolled subject underwent bilateral surgery in May 2018, the last subject completed the last study visit in July 2019.

Unit of analysis: eyes

Participant milestones

Measure	Study Population Extended Depth of Field (EDOF) Implantable Collamer Lens (ICL) implanted into both eyes of eligible subjects. EDOF ICL: The Visian ICL is intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens. It offers an intraocular alternative for the correction of refractive error in those who currently utilize spectacle and/or contact lenses correction.
Overall Study STARTED	35 70
Overall Study COMPLETED	34 68
Overall Study NOT COMPLETED	1 2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Performance of a Phakic Intraocular Lens (IOL)

Baseline characteristics by cohort

Measure	Study Population n=70 eyes EDOF ICL implanted into both eyes of eligible subjects. EDOF ICL: The Visian ICL is intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens. It offers an intraocular alternative for the correction of refractive error in those who currently utilize spectacle and/or contact lenses correction.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	35 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	11 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	0 Participants n=5 Participants
Race (NIH/OMB) White	35 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
Region of Enrollment Belgium	10 Participants n=5 Participants
Region of Enrollment Spain	25 Participants n=5 Participants
Monocular UNVA better than 20/40 at Preoperative Visit	15 Eyes n=32 eyes

PRIMARY outcome

Timeframe: 6 months

Number of Eyes with Monocular Uncorrected Near Visual Acuity of 20/40 or better at 40 cm six months after implantation

Outcome measures

Measure

Study Population n=68 Eyes EDOF ICL implanted into both eyes of eligible subjects. EDOF ICL: The Visian ICL is intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens. It offers an intraocular alternative for the correction of refractive error in those who currently utilize spectacle and/or contact lenses correction.

Number of Eyes With Monocular Uncorrected Near Visual Acuity of 20/40 or Better at 40 cm 6 Months After Implantation

66 Eyes

SECONDARY outcome

Timeframe: 1 month

Percentage of implanted eyes achieving Monocular Uncorrected Near Visual Acuity (UNVA) of 20/40 or better at 40 cm 1 month after implantation

Outcome measures

Measure

Study Population n=68 Eyes EDOF ICL implanted into both eyes of eligible subjects. EDOF ICL: The Visian ICL is intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens. It offers an intraocular alternative for the correction of refractive error in those who currently utilize spectacle and/or contact lenses correction.

Percentage of Implanted Eyes Achieving Monocular Uncorrected Near Visual Acuity of 20/40 or Better at 40 cm 1 Month After Implantation

66 Eyes

SECONDARY outcome

Timeframe: 3 months

Percentage of implanted eyes achieving Monocular Uncorrected Near Visual Acuity (UNVA) of 20/40 or better at 40 cm 3 months after implantation

Outcome measures

Measure

Study Population n=68 Eyes EDOF ICL implanted into both eyes of eligible subjects. EDOF ICL: The Visian ICL is intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens. It offers an intraocular alternative for the correction of refractive error in those who currently utilize spectacle and/or contact lenses correction.

Percentage of Implanted Eyes Achieving Monocular Uncorrected Near Visual Acuity of 20/40 or Better at 40 cm 3 Months After Implantation

66 Eyes

SECONDARY outcome

Timeframe: Baseline and 1 month

Change from baseline in Monocular Uncorrected Intermediate Visual Acuity (UIVA) at 80 cm 1 month post implantation

Outcome measures

Measure

Study Population n=68 Eyes EDOF ICL implanted into both eyes of eligible subjects. EDOF ICL: The Visian ICL is intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens. It offers an intraocular alternative for the correction of refractive error in those who currently utilize spectacle and/or contact lenses correction.

Change From Baseline in Monocular Uncorrected Intermediate Visual Acuity at 80 cm 1 Month Post Implantation

7.63 Lines of Vision Gained Standard Deviation 3.42

SECONDARY outcome

Timeframe: Baseline and 3 months

Change from baseline in Monocular Uncorrected Intermediate Visual Acuity (UIVA) at 80 cm 3 months post implantation

Outcome measures

Measure

Study Population n=68 Eyes EDOF ICL implanted into both eyes of eligible subjects. EDOF ICL: The Visian ICL is intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens. It offers an intraocular alternative for the correction of refractive error in those who currently utilize spectacle and/or contact lenses correction.

Change From Baseline in Monocular Uncorrected Intermediate Visual Acuity at 80 cm 3 Months Post Implantation

7.69 Lines of Vision Gained Standard Deviation 3.48

SECONDARY outcome

Timeframe: Baseline and 6 months

Change from baseline in Monocular Uncorrected Intermediate Visual Acuity (UIVA) at 80 cm 6 months post implantation

Outcome measures

Measure

Study Population n=68 Eyes EDOF ICL implanted into both eyes of eligible subjects. EDOF ICL: The Visian ICL is intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens. It offers an intraocular alternative for the correction of refractive error in those who currently utilize spectacle and/or contact lenses correction.

Change From Baseline in Monocular Uncorrected Intermediate Visual Acuity at 80 cm 6 Months Post Implantation

7.79 Lines of Vision Gained Standard Deviation 3.53

SECONDARY outcome

Timeframe: Baseline and 1 month

Change from baseline in Monocular Uncorrected Near Visual Acuity (UNVA) at 40 cm 1 month post implantation

Outcome measures

Measure

Study Population n=68 Eyes EDOF ICL implanted into both eyes of eligible subjects. EDOF ICL: The Visian ICL is intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens. It offers an intraocular alternative for the correction of refractive error in those who currently utilize spectacle and/or contact lenses correction.

Change From Baseline in Monocular Uncorrected Near Visual Acuity at 40 cm 1 Month Post Implantation

5.96 Lines of Vision Gained Standard Deviation 3.9

SECONDARY outcome

Timeframe: Baseline and 3 months

Change from baseline in Monocular Uncorrected Near Visual Acuity (UNVA) at 40 cm 3 months post implantation

Outcome measures

Measure

Study Population n=68 Eyes EDOF ICL implanted into both eyes of eligible subjects. EDOF ICL: The Visian ICL is intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens. It offers an intraocular alternative for the correction of refractive error in those who currently utilize spectacle and/or contact lenses correction.

Change From Baseline in Monocular Uncorrected Near Visual Acuity at 40 cm 3 Months Post Implantation

5.93 Lines of Vision Gained Standard Deviation 4.05

SECONDARY outcome

Timeframe: Baseline and 6 months

Change from baseline in Monocular Uncorrected Near Visual Acuity (UNVA) at 40 cm 6 months post implantation

Outcome measures

Measure

Study Population n=68 Eyes EDOF ICL implanted into both eyes of eligible subjects. EDOF ICL: The Visian ICL is intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens. It offers an intraocular alternative for the correction of refractive error in those who currently utilize spectacle and/or contact lenses correction.

Change From Baseline in Monocular Uncorrected Near Visual Acuity at 40 cm 6 Months Post Implantation

6.22 Lines of Vision Gained Standard Deviation 3.95

SECONDARY outcome

Timeframe: Baseline and 1 month

Change from baseline in Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) at 80 cm 1 month post implantation

Outcome measures

Measure

Study Population n=68 Eyes EDOF ICL implanted into both eyes of eligible subjects. EDOF ICL: The Visian ICL is intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens. It offers an intraocular alternative for the correction of refractive error in those who currently utilize spectacle and/or contact lenses correction.

Change From Baseline in Monocular Distance Corrected Intermediate Visual Acuity at 80 cm 1 Month Post Implantation

.24 Lines of Vision Gained Standard Deviation 2

SECONDARY outcome

Timeframe: Baseline and 3 months

Change from baseline in Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) at 80 cm 3 months post implantation

Outcome measures

Measure

Study Population n=68 Eyes EDOF ICL implanted into both eyes of eligible subjects. EDOF ICL: The Visian ICL is intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens. It offers an intraocular alternative for the correction of refractive error in those who currently utilize spectacle and/or contact lenses correction.

Change From Baseline in Monocular Distance Corrected Intermediate Visual Acuity at 80 cm 3 Months Post Implantation

.31 Lines of Vision Gained Standard Deviation 2.02

SECONDARY outcome

Timeframe: Baseline and 6 months

Change from baseline in Monocular Distance corrected intermediate visual acuity (DCIVA) at 80 cm 6 months post implantation

Outcome measures

Measure

Study Population n=68 Eyes EDOF ICL implanted into both eyes of eligible subjects. EDOF ICL: The Visian ICL is intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens. It offers an intraocular alternative for the correction of refractive error in those who currently utilize spectacle and/or contact lenses correction.

Change From Baseline in Monocular Distance Corrected Intermediate Visual Acuity at 80 cm 6 Months Post Implantation

.44 Lines of Vision Gained Standard Deviation 2.09

SECONDARY outcome

Timeframe: Baseline and 1 month

Change from baseline in Monocular Distance Corrected Near Visual Acuity (DCNVA) at 40 cm 1 month post implantation

Outcome measures

Measure

Study Population n=68 Eyes EDOF ICL implanted into both eyes of eligible subjects. EDOF ICL: The Visian ICL is intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens. It offers an intraocular alternative for the correction of refractive error in those who currently utilize spectacle and/or contact lenses correction.

Change From Baseline in Monocular Distance Corrected Near Visual Acuity at 40 cm 1 Month Post Implantation

1 Lines of Vision Gained Standard Deviation 1.6

SECONDARY outcome

Timeframe: Baseline and 3 months

Change from baseline in Monocular Distance Corrected Near Visual Acuity (DCNVA) at 40 cm 3 months post implantation

Outcome measures

Measure

Study Population n=68 Eyes EDOF ICL implanted into both eyes of eligible subjects. EDOF ICL: The Visian ICL is intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens. It offers an intraocular alternative for the correction of refractive error in those who currently utilize spectacle and/or contact lenses correction.

Change From Baseline in Monocular Distance Corrected Near Visual Acuity at 40 cm 3 Months Post Implantation

.92 Lines of Vision Gained Standard Deviation 1.74

SECONDARY outcome

Timeframe: Baseline and 6 months

Change from baseline in Monocular Distance Corrected Near Visual Acuity (DCNVA) at 40 cm 6 months post implantation

Outcome measures

Measure

Study Population n=68 Eyes EDOF ICL implanted into both eyes of eligible subjects. EDOF ICL: The Visian ICL is intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens. It offers an intraocular alternative for the correction of refractive error in those who currently utilize spectacle and/or contact lenses correction.

Change From Baseline in Monocular Distance Corrected Near Visual Acuity at 40 cm 6 Months Post Implantation

1.11 Lines of Vision Gained Standard Deviation 1.62

SECONDARY outcome

Timeframe: Baseline and 1 month

Change from baseline in Binocular Uncorrected Near Visual Acuity (UNVA) at 40 cm 1 month post implantation

Outcome measures

Measure

Study Population n=34 Participants EDOF ICL implanted into both eyes of eligible subjects. EDOF ICL: The Visian ICL is intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens. It offers an intraocular alternative for the correction of refractive error in those who currently utilize spectacle and/or contact lenses correction.

Change From Baseline in Binocular Uncorrected Near Visual Acuity at 40 cm 1 Month Post Implantation

5.95 Lines of Vision Gained Standard Deviation 3.99

SECONDARY outcome

Timeframe: Baseline and 3 months

Change from baseline in Binocular Uncorrected Near Visual Acuity (UNVA) at 40 cm 3 months post implantation

Outcome measures

Measure

Study Population n=34 Participants EDOF ICL implanted into both eyes of eligible subjects. EDOF ICL: The Visian ICL is intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens. It offers an intraocular alternative for the correction of refractive error in those who currently utilize spectacle and/or contact lenses correction.

Change From Baseline in Binocular Uncorrected Near Visual Acuity at 40 cm 3 Months Post Implantation

5.99 Lines of Vision Gained Standard Deviation 4.01

SECONDARY outcome

Timeframe: Baseline and 6 months

Change from baseline in Binocular Uncorrected Near Visual Acuity (UCNVA) at 40 cm 6 months post implantation

Outcome measures

Measure

Study Population n=34 Participants EDOF ICL implanted into both eyes of eligible subjects. EDOF ICL: The Visian ICL is intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens. It offers an intraocular alternative for the correction of refractive error in those who currently utilize spectacle and/or contact lenses correction.

Change From Baseline in Binocular Uncorrected Near Visual Acuity at 40 cm 6 Months Post Implantation

6.12 Lines of Vision Gained Standard Deviation 3.96

Adverse Events

Study Population

Serious events: 9 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Measure	Study Population n=35 participants at risk EDOF ICL implanted into both eyes of eligible subjects. EDOF ICL: The Visian ICL is intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens. It offers an intraocular alternative for the correction of refractive error in those who currently utilize spectacle and/or contact lenses correction.
Eye disorders Visual Acuity Reduced	25.7% 9/35 • Number of events 11 • 6 months
Nervous system disorders Vascular Migraine with Aura	2.9% 1/35 • Number of events 1 • 6 months

Other adverse events

Measure	Study Population n=35 participants at risk EDOF ICL implanted into both eyes of eligible subjects. EDOF ICL: The Visian ICL is intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens. It offers an intraocular alternative for the correction of refractive error in those who currently utilize spectacle and/or contact lenses correction.
Eye disorders Visual Acuity Reduced	22.9% 8/35 • Number of events 12 • 6 months
Eye disorders Dry Eye	14.3% 5/35 • Number of events 5 • 6 months
Eye disorders Corneal Oedema	5.7% 2/35 • Number of events 2 • 6 months
Eye disorders Eye Pruritus	2.9% 1/35 • Number of events 1 • 6 months
Eye disorders Eye Inflammation	2.9% 1/35 • Number of events 1 • 6 months
Eye disorders Lacrimation Increased	2.9% 1/35 • Number of events 1 • 6 months
Infections and infestations Hordeolum	5.7% 2/35 • Number of events 4 • 6 months
Infections and infestations Conjunctivitis	2.9% 1/35 • Number of events 1 • 6 months
Investigations Intraocular Pressure Increased	8.6% 3/35 • Number of events 3 • 6 months
Injury, poisoning and procedural complications Conjunctival Laceration	2.9% 1/35 • Number of events 1 • 6 months

Additional Information

Joanne Egamino

STAAR Surgical

Phone: 626-303-7902

Email: jegamino@staar.com

Results disclosure agreements

• Principal investigator is a sponsor employee All data generated from the study will be regarded as confidential, until appropriate analysis and review by the Sponsor or its designee are completed. The results of the study may be published or presented by the Investigator(s) after review by, and in consultation and agreement with the Sponsor, and such that confidential or proprietary information is not disclosed. Prior to publication or presentation, a copy of the final text should be forwarded to the Sponsor or designee for comment.
• Publication restrictions are in place

Restriction type: OTHER