Effect of Minimising Ultrasound Power to 1% During Cataract Surgery on Corneal Endothelium. (OCTOPUS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Dr. Ram Manohar Lohia Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Dr. Ram Manohar Lohia Hospital
ClinicalTrials.gov Identifier:
NCT01259349
First received: December 6, 2010
Last updated: December 14, 2010
Last verified: November 2010
  Purpose

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.


Condition Intervention Phase
Cataract
Procedure: one percent ultrasound power in CMICS
Procedure: 40 percent ultrasound power in CMICS
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Standard Coaxial Microincision Cataract Surgery Versus Coaxial Microincision Cataract Surgery Using 1% Ultrasound in Immature Senile Cataract :a Corneal Endothelium Study

Resource links provided by NLM:


Further study details as provided by Dr. Ram Manohar Lohia Hospital:

Primary Outcome Measures:
  • change in endothelial cell count from baseline over time [ Time Frame: 1 day,1week,months 1,3,6,9,12 ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • change in Intraocular pressure from baseline [ Time Frame: 1day,1week,months1,3,6,9,12 ] [ Designated as safety issue: Yes ]
    Intraocular pressure will be measured using applanation tonometer.

  • visual acuity [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    snellens visual acuity will be converted to Logmar scale and recorded with and without spectacle correction

  • posterior capsular rupture [ Time Frame: day 0 of surgery ] [ Designated as safety issue: Yes ]
    any incidence of posterior capsular rupture during surgery would be noted


Estimated Enrollment: 72
Study Start Date: November 2010
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: one percent ultrasound
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
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.
Other Name: OCTOPUS
Active Comparator: 40 percent ultrasound
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
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.
Other Name: standard CMICS

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients with pre-operative endothelial cell density count less than 1500cells/mm2.
  2. All eye pathologies that can compromise the visual recovery.
  3. Eyes with any kind of corneal dystrophy or corneal scars preventing visualisation of cataract for reliable grading.
  4. Raised intraocular pressure (> 21 mmHg).
  5. Previous intraocular surgery.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01259349

Contacts
Contact: Taru Dewan, MS FRCSEd 0091-9810673180 tarudewan@hotmail.com
Contact: Praveen K Malik, MS 0091-9810405681 praveenk002@yahoo.com

Locations
India
Dr. R.M.L.Hospital, Recruiting
New Delhi, Delhi, India, 110001
Contact: Taru Dewan, MS,FRCSEd    0091-9810673180    tarudewan@hotmail.com   
Contact: Praveen K Malik, MS    009109810405681    praveenk002@yahoo.com   
Principal Investigator: Taru Dewan, MS FRCSEd         
Sponsors and Collaborators
Dr. Ram Manohar Lohia Hospital
Investigators
Principal Investigator: Taru Dewan, MS FRCSEd Dr. R.M.L.Hospital,New Delhi,India
  More Information

No publications provided

Responsible Party: Dr. Taru Dewan, Dr. Ram Manohar Lohia Hospital
ClinicalTrials.gov Identifier: NCT01259349     History of Changes
Other Study ID Numbers: RMLH-002-EYE
Study First Received: December 6, 2010
Last Updated: December 14, 2010
Health Authority: India: Indian Council of Medical Research

Keywords provided by Dr. Ram Manohar Lohia Hospital:
cataract,
phacoemulsification,
one percent ultrasound
endothelial cell density

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on August 26, 2014