Trial Outcomes & Findings for ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens (IOL) (NCT NCT00684138)

NCT ID: NCT00684138

Last Updated: 2010-07-13

Results Overview

Binocular Distance Corrected Near Visual Acuity at Best Distance (that which provides the subject with the best vision)measured in mean logMAR. logMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA). Mean logMAR is the average value of visual acuity.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 300 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2010-07-13

Participant Flow

Only adult subjects of either gender or any race in need of cataract extraction in both eyes were considered for enrollment. 280 subjects were implanted bilaterally with either the ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power IOL Model SN6AD1 or the ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power IOL Model SN6AD3 based upon a 1:1 randomization.

Subjects were examined to ensure inclusion/exclusion criteria. Only subjects who signed an informed consent and qualified to be in the study were enrolled. Subject numbers were assigned after obtaining consent meeting inclusion/exclusion criteria. Subjects were considered enrolled once implanted in the first operative eye.

Participant milestones

Measure	ACRYSOF® ReSTOR® +3.0 ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens	ACRYSOF® ReSTOR® Aspheric +4.0 ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
Overall Study STARTED	141	139
Overall Study COMPLETED	138	131
Overall Study NOT COMPLETED	3	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens (IOL)

Baseline characteristics by cohort

Measure	ACRYSOF® ReSTOR® +3.0 n=141 Participants ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens	ACRYSOF® ReSTOR® Aspheric +4.0 n=139 Participants ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens	Total n=280 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	51 Participants n=5 Participants	40 Participants n=7 Participants	91 Participants n=5 Participants
Age, Categorical >=65 years	90 Participants n=5 Participants	99 Participants n=7 Participants	189 Participants n=5 Participants
Sex: Female, Male Female	95 Participants n=5 Participants	97 Participants n=7 Participants	192 Participants n=5 Participants
Sex: Female, Male Male	46 Participants n=5 Participants	42 Participants n=7 Participants	88 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Only patients bilaterally implanted with the test article were considered for the outcome measures. One study lens was removed following implantation, but prior to surgery completion, resulting in 279 subjects who were implanted and available for postoperative follow-up (evaluable for All Implanted Analysis).

Binocular Distance Corrected Near Visual Acuity at Best Distance (that which provides the subject with the best vision)measured in mean logMAR. logMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA). Mean logMAR is the average value of visual acuity.

Outcome measures

Measure	ACRYSOF® ReSTOR® +3.0 n=138 Participants ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens	ACRYSOF® ReSTOR® Aspheric +4.0 n=131 Participants ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
Binocular Distance Corrected Near Visual Acuity at Best Distance (That Which Provides the Subject With the Best Vision)	0.07 logMAR Interval 0.0539 to 0.0854	0.09 logMAR Interval 0.0854 to 0.1081

SECONDARY outcome

Timeframe: 3 months post-operative

Population: Only patients bilaterally implanted with the test article were considered for the outcome measures. One study lens was removed following implantation, but prior to surgery completion, resulting in 279 subjects who were implanted and available for postoperative follow-up (evaluable for All Implanted Analysis).

Binocular Distance Corrected Distance Visual Acuity measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA).

Outcome measures

Measure	ACRYSOF® ReSTOR® +3.0 n=138 Participants ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens	ACRYSOF® ReSTOR® Aspheric +4.0 n=131 Participants ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
Binocular Distance Corrected Distance Visual Acuity	-0.05 logMAR Interval -0.065 to -0.04	-0.05 logMAR Interval -0.061 to -0.039

SECONDARY outcome

Timeframe: 3 months post-operative

Population: Only patients bilaterally implanted with the test article were considered for the outcome measures. One study lens was removed following implantation, but prior to surgery completion, resulting in 279 subjects who were implanted and available for postoperative follow-up (evaluable for All Implanted Analysis).

Binocular Distance Corrected Intermediate Visual Acuity (tested at 50 cm) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA).

Outcome measures

Measure	ACRYSOF® ReSTOR® +3.0 n=138 Participants ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens	ACRYSOF® ReSTOR® Aspheric +4.0 n=131 Participants ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
Binocular Distance Corrected Intermediate Visual Acuity (Tested at 50 cm)	0.06 logMAR Interval 0.0384 to 0.0849	0.24 logMAR Interval 0.2188 to 0.2667

SECONDARY outcome

Timeframe: 3 months post-operative

Population: Only patients bilaterally implanted with the test article were considered for the outcome measures. One study lens was removed following implantation, but prior to surgery completion, resulting in 279 subjects who were implanted and available for postoperative follow-up (evaluable for All Implanted Analysis).

Binocular Distance Corrected Intermediate Visual Acuity (tested at 60 cm)measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA).

Outcome measures

Measure	ACRYSOF® ReSTOR® +3.0 n=138 Participants ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens	ACRYSOF® ReSTOR® Aspheric +4.0 n=131 Participants ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
Binocular Distance Corrected Intermediate Visual Acuity (Tested at 60 cm)	0.12 logMAR Interval 0.0916 to 0.1381	0.32 logMAR Interval 0.2972 to 0.3451

SECONDARY outcome

Timeframe: 3 months post-operative

Population: Only patients bilaterally implanted with the test article were considered for the outcome measures. One study lens was removed following implantation, but prior to surgery completion, resulting in 279 subjects who were implanted and available for postoperative follow-up (evaluable for All Implanted Analysis).

Binocular Distance Corrected Intermediate Visual Acuity (tested at 70 cm) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA).

Outcome measures

Measure	ACRYSOF® ReSTOR® +3.0 n=138 Participants ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens	ACRYSOF® ReSTOR® Aspheric +4.0 n=131 Participants ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
Binocular Distance Corrected Intermediate Visual Acuity (Tested at 70 cm)	0.18 logMAR Interval 0.1597 to 0.2062	0.34 logMAR Interval 0.319 to 0.3669

Adverse Events

ACRYSOF® ReSTOR® +3.0 (First Eyes)

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

ACRYSOF® ReSTOR® Aspheric +4.0 (First Eyes)

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

ACRYSOF® ReSTOR® +3.0 (Second Eyes)

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

ACRYSOF® ReSTOR® Aspheric +4.0 (Second Eyes)

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	ACRYSOF® ReSTOR® +3.0 (First Eyes) n=153 participants at risk ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens - First eye implanted only	ACRYSOF® ReSTOR® Aspheric +4.0 (First Eyes) n=147 participants at risk ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens - First eye implanted only	ACRYSOF® ReSTOR® +3.0 (Second Eyes) n=151 participants at risk ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens - Second eye implanted only	ACRYSOF® ReSTOR® Aspheric +4.0 (Second Eyes) n=143 participants at risk ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens - Second eye implanted only
Eye disorders Hypopyon	0.65% 1/153 • Number of events 1 • Up to six months after cataract surgery. Adverse events were collected from the time of cataract surgery until pre-market approval submission for all 300 patients enrolled in the study.	0.00% 0/147 • Up to six months after cataract surgery. Adverse events were collected from the time of cataract surgery until pre-market approval submission for all 300 patients enrolled in the study.	0.00% 0/151 • Up to six months after cataract surgery. Adverse events were collected from the time of cataract surgery until pre-market approval submission for all 300 patients enrolled in the study.	0.00% 0/143 • Up to six months after cataract surgery. Adverse events were collected from the time of cataract surgery until pre-market approval submission for all 300 patients enrolled in the study.
Eye disorders Endophthalmitis	0.65% 1/153 • Number of events 1 • Up to six months after cataract surgery. Adverse events were collected from the time of cataract surgery until pre-market approval submission for all 300 patients enrolled in the study.	0.00% 0/147 • Up to six months after cataract surgery. Adverse events were collected from the time of cataract surgery until pre-market approval submission for all 300 patients enrolled in the study.	0.00% 0/151 • Up to six months after cataract surgery. Adverse events were collected from the time of cataract surgery until pre-market approval submission for all 300 patients enrolled in the study.	0.00% 0/143 • Up to six months after cataract surgery. Adverse events were collected from the time of cataract surgery until pre-market approval submission for all 300 patients enrolled in the study.
Eye disorders Macular Edema	2.6% 4/153 • Number of events 4 • Up to six months after cataract surgery. Adverse events were collected from the time of cataract surgery until pre-market approval submission for all 300 patients enrolled in the study.	1.4% 2/147 • Number of events 2 • Up to six months after cataract surgery. Adverse events were collected from the time of cataract surgery until pre-market approval submission for all 300 patients enrolled in the study.	0.00% 0/151 • Up to six months after cataract surgery. Adverse events were collected from the time of cataract surgery until pre-market approval submission for all 300 patients enrolled in the study.	0.70% 1/143 • Number of events 1 • Up to six months after cataract surgery. Adverse events were collected from the time of cataract surgery until pre-market approval submission for all 300 patients enrolled in the study.
Eye disorders Lens Dislocation	0.65% 1/153 • Number of events 1 • Up to six months after cataract surgery. Adverse events were collected from the time of cataract surgery until pre-market approval submission for all 300 patients enrolled in the study.	0.00% 0/147 • Up to six months after cataract surgery. Adverse events were collected from the time of cataract surgery until pre-market approval submission for all 300 patients enrolled in the study.	0.00% 0/151 • Up to six months after cataract surgery. Adverse events were collected from the time of cataract surgery until pre-market approval submission for all 300 patients enrolled in the study.	0.00% 0/143 • Up to six months after cataract surgery. Adverse events were collected from the time of cataract surgery until pre-market approval submission for all 300 patients enrolled in the study.
Surgical and medical procedures Surgical reintervention (SI)	1.3% 2/153 • Number of events 5 • Up to six months after cataract surgery. Adverse events were collected from the time of cataract surgery until pre-market approval submission for all 300 patients enrolled in the study.	0.68% 1/147 • Number of events 1 • Up to six months after cataract surgery. Adverse events were collected from the time of cataract surgery until pre-market approval submission for all 300 patients enrolled in the study.	1.3% 2/151 • Number of events 2 • Up to six months after cataract surgery. Adverse events were collected from the time of cataract surgery until pre-market approval submission for all 300 patients enrolled in the study.	1.4% 2/143 • Number of events 2 • Up to six months after cataract surgery. Adverse events were collected from the time of cataract surgery until pre-market approval submission for all 300 patients enrolled in the study.

Other adverse events

Adverse event data not reported

Additional Information

Alcon Clinical

Alcon Research, Ltd.

Phone: 888.451.3937; 817.568.6725

Email: medinfo@alconlabs.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER