BSSPlus Versus Lactated Ringer's for Phacoemulsification

NCT ID: NCT00801359

Last Updated: 2008-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-10-31

Brief Summary

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Two intraocular irrigating solutions (BSSPlus versus Lactated Ringer's) are compared in this prospective, randomized, masked trial to investigate for differences in preservation of corneal integrity after phacoemulsification cataract surgery.

Detailed Description

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Conditions

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Cataract

Keywords

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cataract phacoemulsification irrigation solution endothelial cell density corneal thickness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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BSSplus

Group Type ACTIVE_COMPARATOR

Phacoemulsification

Intervention Type PROCEDURE

BSSPlus solution

Intervention Type DRUG

Ringer

Group Type EXPERIMENTAL

Phacoemulsification

Intervention Type PROCEDURE

Lactated Ringer's solution

Intervention Type DRUG

Interventions

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Phacoemulsification

Intervention Type PROCEDURE

BSSPlus solution

Intervention Type DRUG

Lactated Ringer's solution

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with senile cataract
* Visual acuity between 20/400 and 20/40

Exclusion Criteria

* Presence of corneal opacity
* Presence of corneal disease
* Traumatic, toxic, hereditary (congenital)and complicated cataracts(uveitis)
* Anterior chamber cells or flare detected before surgery
* Previous ocular surgery
* Any condition which may affect documentation or follow-up
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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University of São Paulo

Locations

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Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto; Centro Avançado de Retina e Catarata

Ribeirão Preto, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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Puckett TR, Peele KA, Howard RS, Kramer KK. Intraocular irrigating solutions. A randomized clinical trial of balanced salt solution plus and dextrose bicarbonate lactated Ringer's solution. Ophthalmology. 1995 Feb;102(2):291-6. doi: 10.1016/s0161-6420(95)31026-3.

Reference Type BACKGROUND
PMID: 7862416 (View on PubMed)

McCarey BE, Polack FM, Marshall W. The phacoemulsification procedure. I. The effect of intraocular irrigating solutions on the corneal endothelium. Invest Ophthalmol. 1976 Jun;15(6):449-57.

Reference Type BACKGROUND
PMID: 931689 (View on PubMed)

Joussen AM, Barth U, Cubuk H, Koch H. Effect of irrigating solution and irrigation temperature on the cornea and pupil during phacoemulsification. J Cataract Refract Surg. 2000 Mar;26(3):392-7. doi: 10.1016/s0886-3350(99)00470-8.

Reference Type BACKGROUND
PMID: 10713235 (View on PubMed)

Kaye GI, Mishima S, Cole JD, Kaye NW. Studies on the cornea. VII. Effects of perfusion with a Ca++-free medium on the corneal endothelium. Invest Ophthalmol. 1968 Feb;7(1):53-66. No abstract available.

Reference Type BACKGROUND
PMID: 5636786 (View on PubMed)

Rosenfeld SI, Waltman SR, Olk RJ, Gordon M. Comparison of intraocular irrigating solutions in pars plana vitrectomy. Ophthalmology. 1986 Jan;93(1):109-15. doi: 10.1016/s0161-6420(86)33790-4.

Reference Type BACKGROUND
PMID: 3513079 (View on PubMed)

Other Identifiers

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8657/2007

Identifier Type: -

Identifier Source: org_study_id