Refractive Change Induced by 2.8-mm Corneal Incision

Study of Refractive Change Induced by 2.8-mm Corneal Incisions for Cataract Surgery

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00742950

Acronym

CINPHA

Enrollment

108

Registered

2008-08-28

Start date

2008-08-31

Completion date

2009-12-31

Last updated

2011-06-27

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

Conditions

Astigmatism, Cataract, Refractive Surgery

Keywords

Corneal incision, Cataract surgery, Phacoemulsification, Surgically induced astigmatism, Corneal Topography

Brief summary

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.

Interventions

PROCEDURENasal 2.8-mm corneal incision

Phacoemulsification through a nasal 2.8-mm incision

PROCEDURETemporal 2.8-mm corneal incision

Phacoemulsification through a 2.8-mm temporal incision

PROCEDURESuperior 2.8-mm incision

Phacoemulsification through a superior 2.8-mm corneal incision

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

50 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
Induced corneal refractive change	6 months

Secondary

Measure	Time frame
ISV change	6 months
Visual acuity	6 months

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 4, 2026