Trial Outcomes & Findings for A Clinical Trial to Evaluate the Safety and Effectiveness of the Raindrop Near Vision Inlay for Pseudophakic Subjects (NCT NCT03017612)

Results Overview

75% of implanted eyes should achieve uncorrected near visual acuity (40cm/16in) of 20/40 or better

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

13 participants

Primary outcome timeframe

12 months postoperatively

Results posted on

2018-03-01

Participant Flow

Participant milestones

Participant milestones
Measure	Single Arm Study Evaluating the safety and effectiveness of the raindrop near vision inlay implanted in bilateral pseudophakic subjects Raindrop Near Vision Inlay: A single-arm study to evaluate the effectiveness of a 2 mm corneal inlay (Raindrop Near Vision Inlay) for the treatment of presbyopia (age-related near vision loss). The anterior curvature of the cornea is re-shaped after implanting the Raindrop Near Vision Inlay in the non-dominant eye under a femtosecond laser flap to improve near and intermediate vision.
Overall Study STARTED	13
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Single Arm Study Evaluating the safety and effectiveness of the raindrop near vision inlay implanted in bilateral pseudophakic subjects Raindrop Near Vision Inlay: A single-arm study to evaluate the effectiveness of a 2 mm corneal inlay (Raindrop Near Vision Inlay) for the treatment of presbyopia (age-related near vision loss). The anterior curvature of the cornea is re-shaped after implanting the Raindrop Near Vision Inlay in the non-dominant eye under a femtosecond laser flap to improve near and intermediate vision.
Overall Study Adverse Event	2

Baseline Characteristics

A Clinical Trial to Evaluate the Safety and Effectiveness of the Raindrop Near Vision Inlay for Pseudophakic Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm Study n=13 Participants Evaluating the safety and effectiveness of the raindrop near vision inlay implanted in bilateral pseudophakic subjects Raindrop Near Vision Inlay: A single-arm study to evaluate the effectiveness of a 2 mm corneal inlay (Raindrop Near Vision Inlay) for the treatment of presbyopia (age-related near vision loss). The anterior curvature of the cornea is re-shaped after implanting the Raindrop Near Vision Inlay in the non-dominant eye under a femtosecond laser flap to improve near and intermediate vision.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	10 Participants n=5 Participants
Race/Ethnicity, Customized African American	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	2 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants
Region of Enrollment United States	13 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months postoperatively

75% of implanted eyes should achieve uncorrected near visual acuity (40cm/16in) of 20/40 or better

Outcome measures

Outcome measures
Measure	Single Arm Study n=13 Participants Evaluating the safety and effectiveness of the raindrop near vision inlay implanted in bilateral pseudophakic subjects Raindrop Near Vision Inlay: A single-arm study to evaluate the effectiveness of a 2 mm corneal inlay (Raindrop Near Vision Inlay) for the treatment of presbyopia (age-related near vision loss). The anterior curvature of the cornea is re-shaped after implanting the Raindrop Near Vision Inlay in the non-dominant eye under a femtosecond laser flap to improve near and intermediate vision.
Percentage of Implanted Eyes With Improvement in Uncorrected Near Vision	100 Percentage of Implanted Eyes

SECONDARY outcome

Timeframe: at 6 months postoperatively and all subsequent time points up to 24 months

Fewer than 5% of eyes should lose two lines or more of best corrected distance and near visual acuity and less than 1% of eyes with preoperative best corrected visual acuity (BCVA) of 20/20 should have best corrected distance and near visual acuity worse than 20/40

Outcome measures

Outcome measures
Measure	Single Arm Study n=12 Participants Evaluating the safety and effectiveness of the raindrop near vision inlay implanted in bilateral pseudophakic subjects Raindrop Near Vision Inlay: A single-arm study to evaluate the effectiveness of a 2 mm corneal inlay (Raindrop Near Vision Inlay) for the treatment of presbyopia (age-related near vision loss). The anterior curvature of the cornea is re-shaped after implanting the Raindrop Near Vision Inlay in the non-dominant eye under a femtosecond laser flap to improve near and intermediate vision.
Preservation of Best Corrected Visual Acuity	92 Percentage of Implanted Eyes

SECONDARY outcome

Timeframe: At 6 months postoperatively and all subsequent time points up to 24 months

Fewer than 5% of eyes should have postoperative manifest refractive astigmatism that increases from baseline by greater than 2.00 D

Outcome measures

Outcome measures
Measure	Single Arm Study n=13 Participants Evaluating the safety and effectiveness of the raindrop near vision inlay implanted in bilateral pseudophakic subjects Raindrop Near Vision Inlay: A single-arm study to evaluate the effectiveness of a 2 mm corneal inlay (Raindrop Near Vision Inlay) for the treatment of presbyopia (age-related near vision loss). The anterior curvature of the cornea is re-shaped after implanting the Raindrop Near Vision Inlay in the non-dominant eye under a femtosecond laser flap to improve near and intermediate vision.
Percentage of Implanted Eyes With a Postoperative Manifest Refraction Astigmatism That Increased From Baseline by Greater Than 2.00 D	0 Percentage of Implanted Eyes

SECONDARY outcome

Timeframe: During the length of the study, up to 24 months

Any specific adverse event should occur in less than or equal to 5% of eyes.

Outcome measures

Outcome measures
Measure	Single Arm Study n=13 Participants Evaluating the safety and effectiveness of the raindrop near vision inlay implanted in bilateral pseudophakic subjects Raindrop Near Vision Inlay: A single-arm study to evaluate the effectiveness of a 2 mm corneal inlay (Raindrop Near Vision Inlay) for the treatment of presbyopia (age-related near vision loss). The anterior curvature of the cornea is re-shaped after implanting the Raindrop Near Vision Inlay in the non-dominant eye under a femtosecond laser flap to improve near and intermediate vision.
Occurrence of Adverse Events Intraocular Pressure increase	2 Occurrence of specific adverse events
Occurrence of Adverse Events Inlay Explant	2 Occurrence of specific adverse events
Occurrence of Adverse Events Diffuse Lamellar Keratitis	1 Occurrence of specific adverse events
Occurrence of Adverse Events Loss of BCVA due to late onset of haze	1 Occurrence of specific adverse events
Occurrence of Adverse Events Hospitalization	1 Occurrence of specific adverse events
Occurrence of Adverse Events Epiretinal Membrane	1 Occurrence of specific adverse events

SECONDARY outcome

Timeframe: at 12 months postoperatively

75% of eyes should achieve uncorrected intermediate visual acuity (80 cm/32 in) of 20/40 or better

Outcome measures

Outcome measures
Measure	Single Arm Study n=12 Participants Evaluating the safety and effectiveness of the raindrop near vision inlay implanted in bilateral pseudophakic subjects Raindrop Near Vision Inlay: A single-arm study to evaluate the effectiveness of a 2 mm corneal inlay (Raindrop Near Vision Inlay) for the treatment of presbyopia (age-related near vision loss). The anterior curvature of the cornea is re-shaped after implanting the Raindrop Near Vision Inlay in the non-dominant eye under a femtosecond laser flap to improve near and intermediate vision.
Uncorrected Intermediate Visual Acuity	92 Percentage of Implanted Eyes

Adverse Events

Single Arm Study

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Single Arm Study n=13 participants at risk Evaluating the safety and effectiveness of the raindrop near vision inlay implanted in bilateral pseudophakic subjects Raindrop Near Vision Inlay: A single-arm study to evaluate the effectiveness of a 2 mm corneal inlay (Raindrop Near Vision Inlay) for the treatment of presbyopia (age-related near vision loss). The anterior curvature of the cornea is re-shaped after implanting the Raindrop Near Vision Inlay in the non-dominant eye under a femtosecond laser flap to improve near and intermediate vision.
Musculoskeletal and connective tissue disorders Hospitalization due to triple arthrodesis surgery (secondary to muscular dystrophy)	7.7% 1/13 • Number of events 1 • 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months

Other adverse events

Other adverse events
Measure	Single Arm Study n=13 participants at risk Evaluating the safety and effectiveness of the raindrop near vision inlay implanted in bilateral pseudophakic subjects Raindrop Near Vision Inlay: A single-arm study to evaluate the effectiveness of a 2 mm corneal inlay (Raindrop Near Vision Inlay) for the treatment of presbyopia (age-related near vision loss). The anterior curvature of the cornea is re-shaped after implanting the Raindrop Near Vision Inlay in the non-dominant eye under a femtosecond laser flap to improve near and intermediate vision.
Eye disorders Increase in intraocular pressure > 10mmHg above baseline	15.4% 2/13 • Number of events 2 • 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months
Eye disorders Inlay explant	15.4% 2/13 • Number of events 2 • 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months
Eye disorders Diffuse Lamellar Keratitis (DLK)	7.7% 1/13 • Number of events 1 • 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months
Eye disorders Loss of BCVA due to late onset of haze	7.7% 1/13 • Number of events 1 • 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months
Eye disorders Epiretinal Membrane	7.7% 1/13 • Number of events 1 • 1 day, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months

Additional Information

Tracy Shwaery, Global Clinical Research Manager

Ms.

Phone: 9497072740

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The investigator agreed to hold this information in confidence and not to disclose it to any third parties for a period of three years from the date of this agreement, or until this information becomes a matter of public knowledge or until a formal agreement for that purpose has been entered into by the parties.
Publication restrictions are in place

Restriction type: OTHER