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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Praveen Kumar Malik, Dr. Ram Manohar Lohia Hospital
ClinicalTrials.gov Identifier:
NCT01256918
First received: December 7, 2010
Last updated: July 7, 2012
Last verified: July 2012
  Purpose

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


Condition
Cataract

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Evaluation of Phacodepth Required to Achieve Full Thickness Nuclear Crack in Various Grades of Cataract and to Determine the Correlation Between the Two.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Phacodepth Required to Achieve Full Thickness Nuclear Crack [ Time Frame: day 0 of surgery ] [ Designated as safety issue: No ]
    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.

  • Correlation Between Nuclear Colour and Phacodepth Required for a Safe and Effective Vertical Chop During Phacoemulsification [ Time Frame: day 0 of surgery ] [ Designated as safety issue: No ]
    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.

  • Correlation Between Nuclear Opalescence and Phacodepth [ Time Frame: day 0 of surgery ] [ Designated as safety issue: No ]

    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

  • Correlation Between Lens Thickness and Phacodepth [ Time Frame: day 0 of surgery ] [ Designated as safety issue: No ]

    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


Secondary Outcome Measures:
  • Posterior Capsular Rupture [ Time Frame: day 0 of surgery. ] [ Designated as safety issue: Yes ]
    A note shall be made of any posterior capsular rupture attributable to the attempted vertical chop .


Enrollment: 200
Study Start Date: November 2010
Study Completion Date: February 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Detailed Description:

BACKGROUND:- Phacochop techniques have been categorized as either horizontal or vertical. These approaches are thought to be among the best techniques for managing hard cataracts. In vertical chop technique proper placement of the phaco tip is crucial. It must be embedded deeply into the centre of the nucleus , pointing toward the optic nerve , with high vacuum and burst mode.Inadequate penetration of phacotip may result in partial thickness nuclear crack with residual posterior plate and overzealous penetration may result in posterior capsular rupture.This may be avoided if some estimate can be made preoperatively of the depth of penetration required to achieve full thickness crack. With this in mind the study intends to make a preoperative assessment of the depth required to reach the centre of the nuclei and observe the actual depth of penetration required for a safe and effective vertical chop.

MATHEMATICAL BASIS :- The cross section of a lens nucleus is ellipsoidal . A geometrical estimate of the radius of the ellipse (x )traversed by the phacotip to reach the centre can be made preoperatively.The calculation would depend largely on three parameters.

The major axis of the ellipse ( namely the lens diameter[b] ) The minor axis of the ellipse (namely lens thickness[a] ) The point of entry on the surface of the lens.This defines an angle Ø which this radius makes with the vertical axis and in turn can be approximated by the length of the arc from centre of lens surface to entry point[y].

Adult human crystalline lens varies in thickness from 4.2+/-0.5 mm and has a diameter of 9.6+/- 0.4mm. Assuming the lens diameter (b) to be from 9.2 mm to 10.0mm , the lens thickness ( a) varying from 3.7mm to 4.7mm and the point of entry of phacotip 2.0mm to 3.0mm from centre of anterior lens surface ( y ) , this distance (x) would vary from 2.59mm to 3.2mm.(using Online Wolfram calculator) in thinnest to thickest nuclei. This would be increased with increase in ( a ) as well as ( y ) .In cataractous lens the harder a nucleus the deeper it may be required to penetrate to achieve a full thickness crack.

If the investigators make a note of all three variables i.e lens thickness , nuclear hardness and point of entry at the time of surgery and correlate with the actual depth required at the time of surgery the investigators may be able to recommend an effective and safe phacodepth for achieving full thickness nuclear crack in various grades of hard cataract.

Till now it was not possible to measure the length of penetration of phacotip during surgery. The investigators have designed a calibrated phacotip with visible markings on 0.2mm scale from 2 to 3. 4mm to enable measurements and recordings.

Thus the investigators aim to identify a safe and effective phacodepth required in each grade of cataract {3.0 - 6.9 according to Lens Opacities Classification System( LOCS-III )}to achieve successful nuclear crack . At the same time any correlation between different nuclear grades and the effective phacodepth would be analysed to find any association between them.

  Eligibility

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

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  1. Subluxated and dislocated lens.
  2. Central leukomatous corneal opacity preventing visualization of cataractous lens for grading and surgery.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01256918

Locations
India
Dr. R.M.L.Hospital,
New Delhi, Delhi, India, 110001
Sponsors and Collaborators
Dr. Ram Manohar Lohia Hospital
Investigators
Principal Investigator: Praveen K Malik, MS Dr. R.M.L.Hospital,New Delhi,India
  More Information

No publications provided

Responsible Party: Dr. Praveen Kumar Malik, Professor and Consultant,ophthalmology, Dr. Ram Manohar Lohia Hospital
ClinicalTrials.gov Identifier: NCT01256918     History of Changes
Other Study ID Numbers: RMLH-001-EYE
Study First Received: December 7, 2010
Results First Received: February 24, 2011
Last Updated: July 7, 2012
Health Authority: India: Indian Council of Medical Research

Keywords provided by Dr. Ram Manohar Lohia Hospital:
cataract
phacoemulsification
phacochop
phacotip

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 17, 2014