NCT01385878

Brief Summary

Cataract surgical techniques have significantly changed in recent years with the widespread adoption of smaller and smaller clear corneal incisions for phacoemulsification. Microincision surgery has many advantages, including reduced surgically induced astigmatism, faster visual recovery, and reduced intra and postoperative inflammation. Curently, microcoaxial phacoemulsification is being performed through 1.8 as well as 2.2 mm incisions. However, there is still a debate as to which is the best absolute incision size for microcoaxial cataract surgery. The aim of this study is to evaluate incision stability following microcoaxial phacoemulsification performed through 1.8 and 2.2 mm systems, as well as compare intraoperative performance and postoperative outcomes following microcoaxial phacoemulsification performed through these two incision sizes.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 30, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

June 30, 2011

Status Verified

June 1, 2011

Enrollment Period

11 months

First QC Date

June 29, 2011

Last Update Submit

June 29, 2011

Conditions

Cataract

Keywords

Microcoaxial phacoemulsification, 1.8mm, 2.2mm

Outcome Measures

Primary Outcomes (1)

  • Ingress of Trypan blue from the Ocular Surface into the Anterior Chamber

    At end of surgery, stromal hydration of all incisions will be performed.0.0125% trypan blue will be instilled on the conjunctival surface.After 2 minutes, the surface will be irrigated with balanced salt solution. 0.1ml aqeous aspirate will be obtained from the anterior chamber.Concentration of trypan blue in the aspirate will be ascertained by UV visible spectrophotometry. Log dilutions of concentration of trypan blue will be used for statistical analysis

    Immediately at the end of surgery

Secondary Outcomes (5)

  • Surgically Induced Astigmatism

    At baseline and 3 months postoperatively

  • Corneal Endothelial Cell Loss

    Baseline and 3 months postoperatively

  • Change in Central Corneal Thickness

    Baseline and 1 week

  • Anterior Chamber Inflammation

    Baseline and 1 week

  • Anterior Chamber Inflammation

    Baseline and 1 month

Study Arms (2)

Phacoemulsification with 1.8mm incision

ACTIVE COMPARATOR

Microcoaxial phacoemulsification was performed using a 1.8mm clear corneal incision

Procedure: Microcoaxial Phacoemulsification

Phacoemulsification with 2.2mm incisi

ACTIVE COMPARATOR

Microcoaxial phacoemulsificaiton will be performed through 2.2mm incision

Procedure: Microcoaxial Phacoemulsification

Interventions

Microcoaxial PhacoemulsificationPROCEDURE

Phacoemulsification through small clear corneal incision

Phacoemulsification with 1.8mm incisionPhacoemulsification with 2.2mm incisi

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Ocular comorbidity, glaucoma, uveitis, shallow anterior chamber, maximal pupillary dilatation \<6mm, high myopia (axial length \> 25mm), previous ocular trauma or surgery, pseudoexfoliation, traumatic cataract, subluxated cataract

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Iladevi Cataract & IOL Research Centre

Ahmedabad, Gujarat, 380009, India

RECRUITING

Related Publications (1)

  • Lee KM, Kwon HG, Joo CK. Microcoaxial cataract surgery outcomes: comparison of 1.8 mm system and 2.2 mm system. J Cataract Refract Surg. 2009 May;35(5):874-80. doi: 10.1016/j.jcrs.2008.12.031.

    PMID: 19393887BACKGROUND

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Abhay R Vasavada, MS, FRCS

    Iladevi Cataract and IOL Research Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Abhay R Vasavada, MS,FRCS

CONTACT

91-79-27490909icirc@abhayvasavada.com

Vaishali A Vasavada, MS

CONTACT

91-79-27492303icirc@abhayvasavada.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 29, 2011

First Posted

June 30, 2011

Study Start

January 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

June 30, 2011

Record last verified: 2011-06

Locations

IN(1)