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Clinical Trials/NL-OMON36197
NL-OMON36197
Completed
Not Applicable

VISUAL OUTCOMES AFTER BILATERAL SURGICAL CATARACT PHACOEMULSIFICATION: ACRYSOF® RESTOR IOL IMPLANTATION COMPARED TO MONOFOCAL IOL IMPLANTATION - Alcon RDG-10-269

Alcon Laboratories0 sites30 target enrollmentTBD
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Conditionscataractcorneaal astigmatism10047518

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
cataract
Sponsor
Alcon Laboratories
Enrollment
30
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
Alcon Laboratories

Eligibility Criteria

Inclusion Criteria

  • •Ocular criteria must be met in both eyes;
  • •\>\= 21 years of age;
  • •willing and able to attend postoperative examinations as per protocol schedule;
  • •have bilateral, age\-related, cataracts;
  • •have planned cataract removal via phacoemulsification with implantation of an IOL;
  • •are available to undergo second eye surgery within 6 weeks of the first eye surgery;
  • •fulfils the recommendations at the \*Warnings\* and \*Precautions\* sections of the AcrySof ReSTOR IOL and Monofocal IOL package inserts;
  • •have either no pre\-operative corneal astigmatism or pre\-operative regular corneal astigmatism \<\=2\.5D;
  • •Both eyes qualify for either AcrySof ReSTOR IOL model SN6AD1 or AcrySof ReSTOR Toric IOLs models SND1T2\-SND1T5 on the AcrySof IOL online calculator provide by the sponsor, as described at session 9\.2\.1 of the protocol 09dec2010\.

Exclusion Criteria

  • •If any of the following exclusion criteria are applicable to either eye, the subject shall not be enrolled in the study;
  • •previous corneal surgery and/or reshaping;
  • •abnormality, disease and/or conditions of the cornea (i.e. keratoconus, corneal dystrophy, severe keratitis, corneal scar, etc.), which would clinically contra\-indicate the implantation of a toric intraocular lens;
  • •planned multiple procedures during cataract/IOL implantation surgery;
  • •planned limbal relaxing incision (LRI), Excimer laser treatment or similar procedure prior to or during the course of the study;

Outcomes

Primary Outcomes

Not specified

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