CataractCALIBCHOPNCT01256918

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

An observational study of Cataract, run by Dr. Ram Manohar Lohia Hospital at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

There is a correlation between phacodepth required for full thickness nuclear crack and the various grades of cataract Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Cataract
How many people: 200 participants
Where: 1 siteIndia
Study dates: Nov 2010to Feb 2011
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

India1 site

Dr. R.M.L.Hospital,
New Delhi, National Capital Territory of Delhi, 110001

Other trials in India

About this study

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.

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

Read the 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.

Conditions: Cataract
Keywords: cataract, phacoemulsification, phacochop, phacotip
Medical subject headings: Cataract

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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
Measured: 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
Measured: day 0 of surgery

Secondary outcomes (1)

Posterior Capsular Rupture
A note shall be made of any posterior capsular rupture attributable to the attempted vertical chop .
Measured: day 0 of surgery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2010Feb 2011

First posted9 Dec 2010 (estimated)
Study startNov 2010
Primary completionJan 2011
Study completionFeb 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for CataractStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Time perspective: Cross-sectional
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01256918
Sponsor's protocol ID: RMLH-001-EYE
Acronym: CALIBCHOP
Status last verified: Jul 2012
First submitted: 7 Dec 2010
Last updated: 16 Aug 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cataract trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT01256918
Acronym / sponsor ID: CALIBCHOP / RMLH-001-EYE
Conditions: Cataract
Keywords: cataract, phacoemulsification, phacochop, phacotip
Study type: Observational
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: Dr. Ram Manohar Lohia HospitalOther government
Study start: Nov 2010
Primary completion: Jan 2011 (actual)
Study completion: Feb 2011 (actual)
First posted: 9 Dec 2010 (estimated)
Results: Posted 16 Aug 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Time perspective: Cross-sectional

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (1 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Phacodepth Required to Achieve Full Thickness Nuclear Crack
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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

1 secondary outcome

Posterior Capsular Rupture
Time frame: day 0 of surgery.

Results and safety

Results posted to the registry on 16 Aug 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients Undergoing Phacoemulsification	200	200

Primary outcome: Phacodepth Required to Achieve Full Thickness Nuclear Crack

Time frame: day 0 of surgery. Mean (Standard Deviation). Unit: mm

Measure	Phacodepth n = 200
Value	2.5755 (0.1816)

Population analysed: 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.

Primary outcome: Correlation Between Nuclear Colour and Phacodepth Required for a Safe and Effective Vertical Chop During Phacoemulsification

Time frame: day 0 of surgery. Mean (Standard Deviation). Unit: units on a scale

Measure	Nuclear Colour n = 200	Phacodepth n = 200
Value	4.7565 (1.2225)	2.5755 (0.1816)

Nuclear Colour vs Phacodepth: pearson correlation coefficient: 0.850958, p <0.05, pearson correlation coefficient

Primary outcome: Correlation Between Nuclear Opalescence and Phacodepth

Time frame: day 0 of surgery. Mean (Standard Deviation). Unit: units on a scale

Measure	Nuclear Opalescence n = 200	Phacodepth n = 200
Value	4.665 (1.2150)	2.5755 (0.1816)

Nuclear Opalescence vs Phacodepth: pearson correlation coefficient: 0.842617, p <0.05, pearson correlation coefficient

Primary outcome: Correlation Between Lens Thickness and Phacodepth

Time frame: day 0 of surgery. Mean (Standard Deviation). Unit: units on a scale

Measure	Lens Thickness n = 200	Phacodepth n = 200
Value	3.9799 (0.5082)	2.5755 (0.1816)

Lens Thickness vs Phacodepth: pearson correlation coefficient: 0.111166, p >0.05, pearson correlation coefficient

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 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 reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients Undergoing Phacoemulsification	0 of 200 (0%)	0 of 200 (0%)	Not reported

Limitations and caveats (from the sponsor): first time use of callibrated phacotip to measure phacotip penetration during vertical chop during phacoemulsification , hence no pre existing results to compare with.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Praveen K Malik, MS principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Cataract, run by Dr. Ram Manohar Lohia Hospital at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phacodepth Required to Achieve Full Thickness Nuclear Crack (time frame: day 0 of surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01256918.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2012.