NCT00521833

Brief Summary

To compare the short-term astigmatic outcomes of phacoemulsification cataract surgery and intraocular lens implantation using temporal versus nasal clear corneal incisions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 27, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 28, 2007

Completed
Last Updated

September 5, 2007

Status Verified

August 1, 2007

First QC Date

August 27, 2007

Last Update Submit

September 4, 2007

Conditions

Surrgical Induced Astigmatism

Keywords

KataractAstigmatismphacoemulsification

Outcome Measures

Primary Outcomes (1)

  • Total and Surgical Induced Astigmatism

    At 1 and 4 weeks and 6 month after surgery

Study Arms (2)

1

EXPERIMENTAL

Temporal (right eye)

Procedure: phacoemulsification and intraocular lens implantation

2

EXPERIMENTAL

Nasal (Left eye)

Procedure: phacoemulsification and intraocular lens implantation

Interventions

phacoemulsification and intraocular lens implantationPROCEDURE

clear cornea phacoemulsification and intraocular lens implantation using temporal or nasal incisions respectively

12

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All the patients with senile cataract

You may not qualify if:

  • Previously operated eyes
  • Presence of corneal pathology
  • Pseudo exfoliation
  • With-the-rule (WTR) astigmatism \>1 D
  • Presence of diabetes mellitus
  • History of connective tissue disease
  • Consumption of systemic steroids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ophthalmic research center

Tehran, Tehran Province, 16666, Iran

Location

MeSH Terms

Conditions

Astigmatism

Interventions

PhacoemulsificationLens Implantation, Intraocular

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Intervention Hierarchy (Ancestors)

Cataract ExtractionRefractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, OperativeUltrasonic Surgical Procedures

Study Officials

  • Mohammad Pakravan, MD

    Shahid Beheshti University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 27, 2007

First Posted

August 28, 2007

Study Start

June 1, 2005

Study Completion

August 1, 2006

Last Updated

September 5, 2007

Record last verified: 2007-08

Locations

IR(1)