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
Recruitment status was Recruiting
Sponsor:
Dr. Ram Manohar Lohia Hospital
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
- Patients of >40yrs will be included in the study.
- Grade 0.1-6.0 (LOCS III grading) of senile cataract.
Exclusion Criteria:
- 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.
Contacts and Locations
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 May 16, 2013