Cataract
Conditions
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Phacodepth Required to Achieve Full Thickness Nuclear Crack | day 0 of surgery | 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 | day 0 of surgery | 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 | day 0 of surgery | 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 | day 0 of surgery | 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
| Measure | Time frame | Description |
|---|---|---|
| Posterior Capsular Rupture | day 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
| Arm | Count |
|---|---|
| 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 |
| Total | 200 |
Baseline characteristics
| Characteristic | Patients Undergoing Phacoemulsification |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 87 Participants |
| Age, Categorical Between 18 and 65 years | 113 Participants |
| Age Continuous | 62.7 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 type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 200 |
| serious Total, serious adverse events | 0 / 200 |
Outcome results
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phacodepth | Correlation Between Lens Thickness and Phacodepth | 3.9799 units on a scale | Standard Deviation 0.5082 |
| Phacodepth | Correlation Between Lens Thickness and Phacodepth | 2.5755 units on a scale | Standard Deviation 0.1816 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phacodepth | Correlation Between Nuclear Colour and Phacodepth Required for a Safe and Effective Vertical Chop During Phacoemulsification | 4.7565 units on a scale | Standard Deviation 1.2225 |
| Phacodepth | Correlation Between Nuclear Colour and Phacodepth Required for a Safe and Effective Vertical Chop During Phacoemulsification | 2.5755 units on a scale | Standard Deviation 0.1816 |
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phacodepth | Correlation Between Nuclear Opalescence and Phacodepth | 4.665 units on a scale | Standard Deviation 1.215 |
| Phacodepth | Correlation Between Nuclear Opalescence and Phacodepth | 2.5755 units on a scale | Standard Deviation 0.1816 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phacodepth | Phacodepth Required to Achieve Full Thickness Nuclear Crack | 2.5755 mm | Standard Deviation 0.1816 |
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phacodepth | Posterior Capsular Rupture | 0 participants |