Contralateral ReSTOR / Monofocal or Phakic Eye

This study has been completed.

Sponsor:

Information provided by:

Alcon Research

ClinicalTrials.gov Identifier:

NCT00731640

First received: August 7, 2008

Last updated: March 19, 2010

Last verified: March 2010

History of Changes

Results First Received: September 9, 2009

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Cataracts
Intervention:	Device: ReSTOR

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This is a retrospective study that required patients with unilateral implantation of the AcrySof ReSTOR Intraocular Lens (IOL). Patients were to be free of conditions or ocular co-morbidities that may affect visual acuity.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
During the preoperative exam, subjects were examined to ensure they met the inclusion/exclusion criteria. Only subjects who signed an informed consent and qualified to be in the study by meeting all inclusion/exclusion criteria were enrolled. This study was not randomized.

Reporting Groups

	Description
Monofocal	Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular Lens (IOL) (unspecified) in other eye
Phakic	Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending

Participant Flow: Overall Study

	Monofocal	Phakic
STARTED	20	32
COMPLETED	20	32
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Monofocal	Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular Lens (IOL) (unspecified) in other eye
Phakic	Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending
Total	Total of all reporting groups

Baseline Measures

	Monofocal	Phakic	Total
Number of Participants [units: participants]	20	32	52
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	8	23	31
>=65 years	12	9	21
Gender [units: participants]
Female	9	13	22
Male	11	19	30

Outcome Measures

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1. Primary:

Visual Acuity [ Time Frame: 6 months ]

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2. Secondary:

Contrast Sensitivity [ Time Frame: 6 Months ]

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3. Secondary:

Patient Satisfaction [ Time Frame: 6 Months Postoperative ]

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4. Secondary:

Spectacle Independence [ Time Frame: 6 Months ]

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Serious Adverse Events

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Reporting Groups

	Description
Monofocal	Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular Lens (IOL) (unspecified) in other eye
Phakic	Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending

Serious Adverse Events

	Monofocal	Phakic
Total, serious adverse events
# participants affected / at risk	0/20 (0.00%)	0/32 (0.00%)

Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Specify: No paper that incorporates Sponsor Confidential Information will be submitted for publication without Sponsor's prior written agreement.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Alcon Clinical
Organization: Alcon Research, Ltd.
phone: 888.451.3937; 817.568.6725
e-mail: medinfo@alconlabs.com

No publications provided

Responsible Party:	Rick Potvin/Director - Global Scientific Market Affairs, Alcon Research
ClinicalTrials.gov Identifier:	NCT00731640 History of Changes
Other Study ID Numbers:	M07-012
Study First Received:	August 7, 2008
Results First Received:	September 9, 2009
Last Updated:	March 19, 2010
Health Authority:	United States: Institutional Review Board

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