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NCT Number: NCT01480557

Aqualase Versus Torsional ip. A Study on Endothelial Cells, Corneal Edema and Corneal Sensitivity

Objective of this study is the comparative assessment of the impact of torsional and liquefaction technologies on endothelial cells (ECC), corneal edema (CCT) and corneal sensitivity (CCS) in a sample of cataract patients.

Participants were recruited from the Cataract Service of the UHA in a consecutive-if-eligible basis. Eligibility criteria included diagnosis of senile cataract with stage 2 nuclear opalescence according to the Lens Opacities Classification System III (LOCS-3) grading scale [10]. By means of a custom computer randomization program all participants randomly populated two study groups according to the cataract-extraction technology used: a) Torsional group (TG) and b) Liquefaction group (LG).

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

55 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Alexandroupolis

Alexandroupoli, Evros, 68100, Greece

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of senile cataract with stage 2 nuclear opalescence according to the Lens Opacities Classification System III (LOCS-3) grading scale

Exclusion criteria

  • Endothelial cell count less than 1900,
  • glaucoma,
  • IOP-lowering medications,
  • former incisional surgery,
  • former diagnosis of corneal disease,
  • diabetes or autoimmune diseases

Treatment and study plan

liquefaction

Procedure

Cataract extraction surgery type

Torsional ip

Procedure

A type cataract surgery using torsional ip technology

Primary outcomes

  1. Endothelial cell count (ECC)

    Time frame: 1 month postoperatively

Secondary outcomes

  1. Uncorrected visual acuity (UVA)

    Time frame: 1 month postoperatively

  2. Central corneal thickness (CCT)

    Time frame: 1 month postoperatively

  3. Central Corneal Sensitivity (CCS)

    Time frame: 1 month postoperatively

Sponsors and collaborators

Lead sponsor

Democritus University of Thrace

Other

Registry information

Official study title

Liquefaction Versus Torsional ip. A Comparative Study on Endothelial Cells, Corneal Edema and Corneal Sensitivity

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Nov 29, 2011
Registry last updated
Jan 18, 2017

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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