Outcomes Following Phacoemulsification With 1.8 & 2.2mm Incision: Randomized Clinical Trial

Iladevi Cataract and IOL Research Center

Status: Unknown

Conditions: Cataract

Treatments: Procedure: Microcoaxial Phacoemulsification

Study type: Interventional

Funder types: Other

Identifiers

NCT01385878

ICIRC-1.8 VS 2.2

Details and patient eligibility

About

Cataract surgical techniques have significantly changed in recent years with the widespread adoption of smaller and smaller clear corneal incisions for phacoemulsification. Microincision surgery has many advantages, including reduced surgically induced astigmatism, faster visual recovery, and reduced intra and postoperative inflammation. Curently, microcoaxial phacoemulsification is being performed through 1.8 as well as 2.2 mm incisions. However, there is still a debate as to which is the best absolute incision size for microcoaxial cataract surgery.

The aim of this study is to evaluate incision stability following microcoaxial phacoemulsification performed through 1.8 and 2.2 mm systems, as well as compare intraoperative performance and postoperative outcomes following microcoaxial phacoemulsification performed through these two incision sizes.

Full description

Cataract surgical techniques have significantly changed in recent years with the widespread adoption of smaller and smaller clear corneal incisions for phacoemulsification. Microincision surgery has many advantages, including reduced surgically induced astigmatism, faster visual recovery, and reduced intra and postoperative inflammation. In the recent times, microcoaxial phacoemulsification has gained popularity. The main advantage of this newer technique is that it uses the same methods as the conventional method but with smaller incisions. Curently, microcoaxial phacoemulsification is being performed through 1.8 as well as 2.2 mm incisions. However, there is still a debate as to which is the best absolute incision size for microcoaxial cataract surgery.

The aim of this study is to evaluate incision stability following microcoaxial phacoemulsification performed through 1.8 and 2.2 mm systems, as well as compare intraoperative performance and postoperative outcomes following microcoaxial phacoemulsification performed through these two incision sizes.

Enrollment: 110 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Uncomplicated age related cataracts, NO grade II III, IV (LOCS III classification)

Exclusion Criteria:

• Ocular comorbidity, glaucoma, uveitis, shallow anterior chamber, maximal pupillary dilatation <6mm, high myopia (axial length > 25mm), previous ocular trauma or surgery, pseudoexfoliation, traumatic cataract, subluxated cataract

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

110 participants in 2 patient groups

Phacoemulsification with 1.8mm incision

Active Comparator group

Description:

Microcoaxial phacoemulsification was performed using a 1.8mm clear corneal incision

Treatment:

Procedure: Microcoaxial Phacoemulsification

Procedure: Microcoaxial Phacoemulsification

Procedure: Microcoaxial Phacoemulsification

Procedure: Microcoaxial Phacoemulsification

Phacoemulsification with 2.2mm incisi

Active Comparator group

Description:

Microcoaxial phacoemulsificaiton will be performed through 2.2mm incision

Treatment:

Procedure: Microcoaxial Phacoemulsification

Procedure: Microcoaxial Phacoemulsification

Procedure: Microcoaxial Phacoemulsification

Procedure: Microcoaxial Phacoemulsification