Refractive Change Induced by 2.8-mm Corneal Incision

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cataract Refractive Surgery Astigmatism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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I

Nasal 2.8-mm corneal incision

Group Type ACTIVE_COMPARATOR

Nasal 2.8-mm corneal incision

Intervention Type PROCEDURE

Phacoemulsification through a nasal 2.8-mm incision

II

Temporal 2.8-mm corneal incision

Group Type ACTIVE_COMPARATOR

Temporal 2.8-mm corneal incision

Intervention Type PROCEDURE

Phacoemulsification through a 2.8-mm temporal incision

III

Superior 2.8-mm corneal incision

Group Type ACTIVE_COMPARATOR

Superior 2.8-mm incision

Intervention Type PROCEDURE

Phacoemulsification through a superior 2.8-mm corneal incision

Interventions

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Nasal 2.8-mm corneal incision

Phacoemulsification through a nasal 2.8-mm incision

Intervention Type PROCEDURE

Temporal 2.8-mm corneal incision

Phacoemulsification through a 2.8-mm temporal incision

Intervention Type PROCEDURE

Superior 2.8-mm incision

Phacoemulsification through a superior 2.8-mm corneal incision

Intervention Type PROCEDURE

Other Intervention Names

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Phacoemulsification nasal incision Phacoemulsification temporal incision Phacoemulsification superior incision

Eligibility Criteria

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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