Study of Phacodepth Required for Safe and Effective Chop During Phacoemulsification for Cataract.

NCT01256918 | Completed Results DMC

• 1 other identifier: RMLH-001-EYE
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

There is a correlation between phacodepth required for full thickness nuclear crack and the various grades of cataract

Conditions

Cataract

Keywords

cataract; phacoemulsification; phacochop; phacotip

Outcome Measures

Primary Outcomes (4)

• Phacodepth Required to Achieve Full Thickness Nuclear Crack

  phacodepth is the term used to describe the depth penetrated by the phacotip into the substance of lens.A note of depth penetrated by the tip to achieve full thickness nuclear crack shall be made.

  day 0 of surgery

• Correlation Between Nuclear Colour and Phacodepth Required for a Safe and Effective Vertical Chop During Phacoemulsification

  the nuclear colour grading as per LOCS III criteria for each case and the depth of penetration of phacotip required during a vertical chop was analysed to look for any correlation between the two.

  day 0 of surgery

• Correlation Between Nuclear Opalescence and Phacodepth

  Pearson correlation coefficient would be calculated to look for any correlation between 1. nuclear opalescence as per LOCS III grading system for each cataract and 2. penetration of phacotip required to achieve a full thickness nuclear crack in vertical chop during phacoemulsification of the cataractous lens

  day 0 of surgery

• Correlation Between Lens Thickness and Phacodepth

  Pearson correlation coefficient would be calculated to look for any correlation between 1. length thickness measurement using A scan biometer for each cataract and 2. penetration of phacotip required to achieve a full thickness nuclear crack in vertical chop during phacoemulsification of the cataractous lens

  day 0 of surgery

Secondary Outcomes (1)

• Posterior Capsular Rupture

  day 0 of surgery.

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will be conducted at EYE DEPARTMENT, Post Graduate Institute of Medical Education and Research(PGIMER) , Dr R.M.L Hospital. A consecutive sample of all eyes with cataract reporting to the eye OPD of Dr. R.M.L.Hospital and fulfilling the inclusion criteria, would be enrolled in the study starting a date following ethics committee approval till March 2011 ,after a written informed consent.

You may qualify if:

• Patients (\> 40 years of age) with grade 3.0 to 6.9( according to LOCS-III) of senile cataract will be included in this study

You may not qualify if:

• Subluxated and dislocated lens.
• Central leukomatous corneal opacity preventing visualization of cataractous lens for grading and surgery.

Sponsors & Collaborators

• Dr. Ram Manohar Lohia Hospital: lead

Study Sites (1)

Dr. R.M.L.Hospital,

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

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Limitations and Caveats

first time use of callibrated phacotip to measure phacotip penetration during vertical chop during phacoemulsification , hence no pre existing results to compare with.

Results Point of Contact

• Title: Dr. Praveen Kumar Malik
• Organization: Dr. Ram Manohar Lohia Hospital

praveenk002@yahoo.com

00919810405681

Study Officials

• Praveen K Malik, MS

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Consultant,ophthalmology

Study Record Dates

• First Submitted: December 7, 2010
• First Posted: December 9, 2010
• Study Start: November 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: February 1, 2011
• Last Updated: August 16, 2012
• Results First Posted: August 16, 2012

Record last verified: 2012-07

Locations

IN (1)