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

Evaluation of Phacodepth Required to Achieve Full Thickness Nuclear Crack in Various Grades of Cataract and to Determine the Correlation Between the Two.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01256918
Acronym
CALIBCHOP
Enrollment
200
Registered
2010-12-09
Start date
2010-11-30
Completion date
2011-02-28
Last updated
2012-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Keywords

cataract, phacoemulsification, phacochop, phacotip

Brief summary

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

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.

Interventions

None listed

Sponsors

Dr. Ram Manohar Lohia Hospital
Lead SponsorOTHER_GOV

Study design

Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Phacodepth Required to Achieve Full Thickness Nuclear Crackday 0 of surgeryphacodepth 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 Phacoemulsificationday 0 of surgerythe 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 Phacodepthday 0 of surgeryPearson 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 Phacodepthday 0 of surgeryPearson 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

MeasureTime frameDescription
Posterior Capsular Ruptureday 0 of surgery.A note shall be made of any posterior capsular rupture attributable to the attempted vertical chop .

Countries

India

Participant flow

Recruitment details

A consecutive sample of 200 eyes with cataract reporting to the eye outpatient department (OPD) of Dr. Ram Manohar Lohia (R.M.L.)Hospital and fulfilling the inclusion criteria, were enrolled in the study starting Nov.2010 till January 2011 ,after a written informed consent.

Participants by arm

ArmCount
Patients Undergoing Phacoemulsification
Patients (\> 40 years of age) with grade 3.0 to 6.9( according to LOCS-III) of senile cataract were included in this study.200 consecutive patients were enrolled and achievement of milestone noted while attempting vertical chop during phacoemulsification using a calibrated phacotip.
200
Total200

Baseline characteristics

CharacteristicPatients Undergoing Phacoemulsification
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
87 Participants
Age, Categorical
Between 18 and 65 years
113 Participants
Age Continuous62.7 years
STANDARD_DEVIATION 10.36
Region of Enrollment
India
200 participants
Sex: Female, Male
Female
111 Participants
Sex: Female, Male
Male
89 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 200
serious
Total, serious adverse events
0 / 200

Outcome results

Primary

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

Time frame: day 0 of surgery

ArmMeasureValue (MEAN)Dispersion
PhacodepthCorrelation Between Lens Thickness and Phacodepth3.9799 units on a scaleStandard Deviation 0.5082
PhacodepthCorrelation Between Lens Thickness and Phacodepth2.5755 units on a scaleStandard Deviation 0.1816
Comparison: null hypothesis there is no correlation between lens thickness and penetration of phacotip (phacodepth)required to achieve full thickness crack in vertical chop during phacoemulsificationp-value: >0.05pearson correlation coefficient
Primary

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.

Time frame: day 0 of surgery

ArmMeasureValue (MEAN)Dispersion
PhacodepthCorrelation Between Nuclear Colour and Phacodepth Required for a Safe and Effective Vertical Chop During Phacoemulsification4.7565 units on a scaleStandard Deviation 1.2225
PhacodepthCorrelation Between Nuclear Colour and Phacodepth Required for a Safe and Effective Vertical Chop During Phacoemulsification2.5755 units on a scaleStandard Deviation 0.1816
Comparison: null hypothesis : there is no correlation between nuclear colour and phacodepth required for a full thickness crack during a vertical chopp-value: <0.05pearson correlation coefficient
Primary

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

Time frame: day 0 of surgery

ArmMeasureValue (MEAN)Dispersion
PhacodepthCorrelation Between Nuclear Opalescence and Phacodepth4.665 units on a scaleStandard Deviation 1.215
PhacodepthCorrelation Between Nuclear Opalescence and Phacodepth2.5755 units on a scaleStandard Deviation 0.1816
Comparison: Null hypothesis:~there is no correlation between nuclear opalescence and phacodepth required to achieve full thickness nuclear crack using a callibrated phacotip.p-value: <0.05pearson correlation coefficient
Primary

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.

Time frame: day 0 of surgery

Population: A consecutive sample of all eyes with cataract reporting to the eye OPD of Dr. R.M.L.Hospital and fulfilling the inclusion criteria, were enrolled in the study starting Nov.2010 till Jan 2011 ,after a written informed consent.

ArmMeasureValue (MEAN)Dispersion
PhacodepthPhacodepth Required to Achieve Full Thickness Nuclear Crack2.5755 mmStandard Deviation 0.1816
Secondary

Posterior Capsular Rupture

A note shall be made of any posterior capsular rupture attributable to the attempted vertical chop .

Time frame: day 0 of surgery.

Population: . In this observational study sample size was achieved by consecutive sampling of all eyes with cataract reporting to the eye OPD of Dr. R.M.L.Hospital and fulfilling the inclusion criteria from Nov.2010 till March 2011 ,after a written informed consent.~Occurence of any posterior capsular rupture during vertical chop was noted as per protocol.

ArmMeasureValue (NUMBER)
PhacodepthPosterior Capsular Rupture0 participants
Comparison: Any occurence of posterior capsular rupture in attempted vertical chop would have been an indicator of overzealous penetration as the vertical chop even though effective would not have been safe.~We hypothesised that use of callibrated phacotip after careful preoperative assessment for performing vertical chop during phacoemulsification is not associated with any posterior capsular rupture we noted any incidence of posterior capsular rupture.p-value: >0.05incidence

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026