NCT00801359

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 3, 2008

Completed
Last Updated

December 16, 2008

Status Verified

December 1, 2008

Enrollment Period

7 months

First QC Date

December 2, 2008

Last Update Submit

December 15, 2008

Conditions

Cataract

Keywords

cataractphacoemulsificationirrigation solutionendothelial cell densitycorneal thickness

Outcome Measures

Primary Outcomes (2)

  • endothelial cell density

    baseline and at 1, 8, 15, 30 and 60 days postoperatively

  • central corneal thickness

    baseline and at 1, 8, 15, 30 and 60 days postoperatively

Secondary Outcomes (1)

  • number of anterior chamber cells and flare grade

    baseline and at 1, 8, 15, 30 and 60 days postoperatively

Study Arms (2)

BSSplus

ACTIVE COMPARATOR
Procedure: PhacoemulsificationDrug: BSSPlus solution

Ringer

EXPERIMENTAL
Procedure: PhacoemulsificationDrug: Lactated Ringer's solution

Interventions

PhacoemulsificationPROCEDURE
BSSplusRinger
BSSPlus solutionDRUG
BSSplus
Lactated Ringer's solutionDRUG
Ringer

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Ribeirão Preto, São Paulo, 14049-900, Brazil

Location

Related Publications (5)

  • 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.

    PMID: 7862416BACKGROUND

  • 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.

    PMID: 931689BACKGROUND

  • 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.

    PMID: 10713235BACKGROUND

  • 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.

    PMID: 5636786BACKGROUND

  • 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.

    PMID: 3513079BACKGROUND

MeSH Terms

Conditions

Cataract

Interventions

PhacoemulsificationRinger's Lactate

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Cataract ExtractionRefractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, OperativeUltrasonic Surgical ProceduresCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 2, 2008

First Posted

December 3, 2008

Study Start

January 1, 2008

Primary Completion

August 1, 2008

Study Completion

October 1, 2008

Last Updated

December 16, 2008

Record last verified: 2008-12

Locations

BR(1)