Refractive Change Induced by 2.8-mm Corneal Incision (CINPHA)

Madrid Health Service

Status: Completed

Conditions: Cataract; Astigmatism; Refractive Surgery

Treatments: Procedure: Temporal 2.8-mm corneal incision; Procedure: Nasal 2.8-mm corneal incision; Procedure: Superior 2.8-mm incision

Study type: Interventional

Funder types: Other

Identifiers

NCT00742950

CINPHACO

Details and patient eligibility

About

The investigators' purpose is to study the induced refractive change caused by different 2.8-mm corneal incision locations in phacoemulsification, because the investigators hypothesize that the effect may be different for nasal, temporal, and superior location, although they are considered astigmatism neutral.

Patients will be randomized to nasal or temporal incision, or assigned to superior incision, depending on preexisting astigmatism. Visual acuity, refraction, keratometry, Pentacam analysis, intraocular pressure, biomicroscopy, and funduscopy, will be carried out before and after phacoemulsification.

Outcome measures will be induced corneal refractive change (Fourier power vector analysis), ISV change, and visual acuity, at 6 months.

Enrollment: 108 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Visual impairment for daily tasks caused by cataract
• Age older than 50 years
• Steep axis of corneal astigmatism at 90° ± 20° or 180° ± 20°
• Ability to cooperate in the protocol procedures

Exclusion criteria

• Age below 50
• Inability to cooperate with measurements

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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108 participants in 3 patient groups

I

Active Comparator group

Description:

Nasal 2.8-mm corneal incision

Treatment:

Procedure: Nasal 2.8-mm corneal incision

II

Active Comparator group

Description:

Temporal 2.8-mm corneal incision

Treatment:

Procedure: Temporal 2.8-mm corneal incision

III

Active Comparator group

Description:

Superior 2.8-mm corneal incision

Treatment:

Procedure: Superior 2.8-mm incision