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Completed

NCT Number: NCT00742950

Refractive Change Induced by 2.8-mm Corneal Incision

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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Key information

Conditions

Cataract Astigmatism Eye Diseases Lens Diseases Refractive Errors Refractive Surgery

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept Ophthalmology, Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nasal 2.8-mm corneal incision

Procedure

Phacoemulsification through a nasal 2.8-mm incision

Other names: Phacoemulsification nasal incision

Temporal 2.8-mm corneal incision

Procedure

Phacoemulsification through a 2.8-mm temporal incision

Other names: Phacoemulsification temporal incision

Superior 2.8-mm incision

Procedure

Phacoemulsification through a superior 2.8-mm corneal incision

Other names: Phacoemulsification superior incision

Primary outcomes

  1. Induced corneal refractive change

    Time frame: 6 months

Secondary outcomes

  1. ISV change

    Time frame: 6 months

  2. Visual acuity

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Hospital Universitario Ramon y Cajal

Other

Registry information

Official study title

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

Acronym: CINPHA

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 28, 2008
Registry last updated
Jun 27, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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