Trial Outcomes & Findings for Study of Phacodepth Required for Safe and Effective Chop During Phacoemulsification for Cataract. (NCT NCT01256918)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

200 participants

Primary outcome timeframe

day 0 of surgery

Results posted on

2012-08-16

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	200
Overall Study Full Thickness Nuclear Crack Achieved	200
Overall Study COMPLETED	200
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients Undergoing Phacoemulsification n=200 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	113 Participants n=5 Participants
Age, Categorical >=65 years	87 Participants n=5 Participants
Age Continuous	62.7 years STANDARD_DEVIATION 10.36 • n=5 Participants
Sex: Female, Male Female	111 Participants n=5 Participants
Sex: Female, Male Male	89 Participants n=5 Participants
Region of Enrollment India	200 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Phacodepth n=200 Participants A note shall be made of the phacodepth at which a complete vertical chop is achieved during the attempted vertical chop .	Phacodepth actual depth of penetration(in mm) of phacotip required to achieve a full thickness crack in vertical chop during phacoemulsification
Phacodepth Required to Achieve Full Thickness Nuclear Crack	2.5755 mm Standard Deviation 0.1816	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Phacodepth n=200 Participants A note shall be made of the phacodepth at which a complete vertical chop is achieved during the attempted vertical chop .	Phacodepth n=200 Participants actual depth of penetration(in mm) of phacotip required to achieve a full thickness crack in vertical chop during phacoemulsification
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	2.5755 units on a scale Standard Deviation 0.1816

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Phacodepth n=200 Participants A note shall be made of the phacodepth at which a complete vertical chop is achieved during the attempted vertical chop .	Phacodepth n=200 Participants actual depth of penetration(in mm) of phacotip required to achieve a full thickness crack in vertical chop during phacoemulsification
Correlation Between Nuclear Opalescence and Phacodepth	4.665 units on a scale Standard Deviation 1.2150	2.5755 units on a scale Standard Deviation 0.1816

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Phacodepth n=200 Participants A note shall be made of the phacodepth at which a complete vertical chop is achieved during the attempted vertical chop .	Phacodepth n=200 Participants actual depth of penetration(in mm) of phacotip required to achieve a full thickness crack in vertical chop during phacoemulsification
Correlation Between Lens Thickness and Phacodepth	3.9799 units on a scale Standard Deviation 0.5082	2.5755 units on a scale Standard Deviation 0.1816

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Phacodepth n=200 Participants A note shall be made of the phacodepth at which a complete vertical chop is achieved during the attempted vertical chop .	Phacodepth actual depth of penetration(in mm) of phacotip required to achieve a full thickness crack in vertical chop during phacoemulsification
Posterior Capsular Rupture	0 participants	—

Adverse Events

Patients Undergoing Phacoemulsification

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Patients Undergoing Phacoemulsification n=200 participants at risk 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.
Eye disorders posterior capsular rupture	0.00% 0/200 • any occurrence of corneal epithelial damage due to A scan biometry during preoperative assessment was noted during the period from day of examination to 24hrs. thereafter for each participant during the entire period of recruitment.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Praveen Kumar Malik

Dr. Ram Manohar Lohia Hospital

Phone: 00919810405681

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place