BSSPlus Versus Lactated Ringer's for Phacoemulsification

University of Sao Paulo

Status and phase: Completed; Phase 2

Conditions: Cataract

Treatments: Drug: BSSPlus solution; Procedure: Phacoemulsification; Drug: Lactated Ringer's solution

Study type: Interventional

Funder types: Other

Identifiers

NCT00801359

8657/2007

Details and patient eligibility

About

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.

Enrollment: 110 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

110 participants in 2 patient groups

BSSplus

Active Comparator group

Treatment:

Procedure: Phacoemulsification

Drug: BSSPlus solution

Ringer

Experimental group

Treatment:

Drug: Lactated Ringer's solution

Procedure: Phacoemulsification