NCT01259349

Brief Summary

Coaxial microincision cataract surgery using 1% ultrasound is not inferior to standard coaxial microincision cataract surgery in patients of grade 0.1-6.0 immature senile cataract in terms of corneal endothelial safety.

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
72

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2010

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 6, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 14, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

December 15, 2010

Status Verified

November 1, 2010

Enrollment Period

5 months

First QC Date

December 6, 2010

Last Update Submit

December 14, 2010

Conditions

Cataract

Keywords

cataract,phacoemulsification,one percent ultrasoundendothelial cell density

Outcome Measures

Primary Outcomes (1)

  • change in endothelial cell count from baseline over time

    Noncontact specular microscope (EM - 3000; TOMEY: VERSION 2A/OJ) will be used to calculate the endothelial cell density, coefficient of variation of cell size, percentage of hexagonal cells and corneal thickness before surgery and 1day, 1 week, 1, 3, 6, 9 and 12 months visits after surgery. 3 endothelial cell photographs will be taken at each visit and the mean cell count of three photographs will be calculated. Counts will be performed by an observer blinded to which procedure the patient had undergone. Endothelial cell loss will be calculated as a percentage of pre operative cell density

    1 day,1week,months 1,3,6,9,12

Secondary Outcomes (3)

  • change in Intraocular pressure from baseline

    1day,1week,months1,3,6,9,12

  • visual acuity

    1 month

  • posterior capsular rupture

    day 0 of surgery

Study Arms (2)

one percent ultrasound

EXPERIMENTAL

Co-axial MICS shall be performed in cases allocated to this arm .The ultrasound power shall be kept at one percent during the surgery.A note of effective phacotime,volume of fluid aspirated and any intraoperative complications shall be made.

Procedure: one percent ultrasound power in CMICS

40 percent ultrasound

ACTIVE COMPARATOR

Co-axial MICS shall be performed in cases allocated to this arm .The ultrasound power shall be kept at 40 percent during the surgery.A note of effective phacotime,volume of fluid aspirated and any intraoperative complications shall be made.

Procedure: 40 percent ultrasound power in CMICS

Interventions

one percent ultrasound power in CMICSPROCEDURE

Co-axial MICS shall be performed in cases allocated to this arm .The ultrasound power shall be kept at one percent during the surgery.A note of effective phacotime,volume of fluid aspirated and any intraoperative complications shall be made.

Also known as: OCTOPUS
one percent ultrasound
40 percent ultrasound power in CMICSPROCEDURE

Co-axial MICS shall be performed in cases allocated to this arm .The ultrasound power shall be kept at 40 percent during the surgery.A note of effective phacotime,volume of fluid aspirated and any intraoperative complications shall be made.

Also known as: standard CMICS
40 percent ultrasound

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients of \>40yrs will be included in the study.
  • Grade 0.1-6.0 (LOCS III grading) of senile cataract.

You may not qualify if:

  • Patients with pre-operative endothelial cell density count less than 1500cells/mm2.
  • All eye pathologies that can compromise the visual recovery.
  • Eyes with any kind of corneal dystrophy or corneal scars preventing visualisation of cataract for reliable grading.
  • Raised intraocular pressure (\> 21 mmHg).
  • Previous intraocular surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. R.M.L.Hospital,

New Delhi, National Capital Territory of Delhi, 110001, India

RECRUITING

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Taru Dewan, MS FRCSEd

    Dr. R.M.L.Hospital,New Delhi,India

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Taru Dewan, MS FRCSEd

CONTACT

0091-9810673180tarudewan@hotmail.com

Praveen K Malik, MS

CONTACT

0091-9810405681praveenk002@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

December 6, 2010

First Posted

December 14, 2010

Study Start

November 1, 2010

Primary Completion

April 1, 2011

Study Completion

April 1, 2012

Last Updated

December 15, 2010

Record last verified: 2010-11

Locations

IN(1)