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BSSPlus Versus Lactated Ringer's for Phacoemulsification

Comparison of Corneal Changes After Phacoemulsification Using BSSPlus Versus Lactated Ringer's Irrigating Solution

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00801359
Enrollment
110
Registered
2008-12-03
Start date
2008-01-31
Completion date
2008-10-31
Last updated
2008-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Keywords

cataract, phacoemulsification, irrigation solution, endothelial cell density, corneal thickness

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.

Interventions

PROCEDUREPhacoemulsification
DRUGBSSPlus solution

Sponsors

University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
endothelial cell densitybaseline and at 1, 8, 15, 30 and 60 days postoperatively
central corneal thicknessbaseline and at 1, 8, 15, 30 and 60 days postoperatively

Secondary

MeasureTime frame
number of anterior chamber cells and flare gradebaseline and at 1, 8, 15, 30 and 60 days postoperatively

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026