CataractPhase 3OCTOPUSNCT01259349
Effect of Minimising Ultrasound Power to 1% During Cataract Surgery on Corneal Endothelium.
A Phase 3 study testing one percent ultrasound power in CMICS and 40 percent ultrasound power in CMICS in people with Cataract, run by Dr. Ram Manohar Lohia Hospital at 1 site in India.
Trial summary
Coaxial microincision cataract surgery using 1% ultrasound is not inferior to standard coaxial microincision cataract surgery in patients of grade 0.1-6.0 immature senile cataract in terms of corneal endothelial safety. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- one percent ultrasound power in CMICS and 40 percent ultrasound power in CMICS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteIndia
- Study dates
- Nov 2010to Apr 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
Who may be able to join
- Patients of >40yrs will be included in the study.
- Grade 0.1-6.0 (LOCS III grading) of senile cataract.
Who cannot join
- Patients with pre-operative endothelial cell density count less than 1500cells/mm2.
- All eye pathologies that can compromise the visual recovery.
- Eyes with any kind of corneal dystrophy or corneal scars preventing visualisation of cataract for reliable grading.
- Raised intraocular pressure (> 21 mmHg).
- Previous intraocular surgery.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Dr. R.M.L.Hospital,
New Delhi, National Capital Territory of Delhi, 110001
Taru Dewan, MS,FRCSEd, 0091-9810673180, tarudewan@hotmail.com
Praveen K Malik, MS, 009109810405681, praveenk002@yahoo.com
About this study
Official title: Standard Coaxial Microincision Cataract Surgery Versus Coaxial Microincision Cataract Surgery Using 1% Ultrasound in Immature Senile Cataract :a Corneal Endothelium Study
Coaxial microincision cataract surgery using 1% ultrasound is not inferior to standard coaxial microincision cataract surgery in patients of grade 0.1-6.0 immature senile cataract in terms of corneal endothelial safety.
Read the detailed description
Corneal endothelial damage and posterior capsular rupture are two most undesirable complications of cataract surgery, infact significant loss of endothelium can lead to corneal decompensation and loss of corneal clarity. However, some degree of endothelial cell loss is inevitable after any cataract surgery. A loss of 3.2%-23.2% has been shown in various studies since 1967. It is well known that during cataract surgery many different factors can generate endothelial damages, these include the impact of the nuclear fragments, the turbulence generated in anterior chamber and the volume of liquid. It is also related to the amount of ultrasonic energy used and the subsequent temperature rise, the contact with surgical instruments and the IOL during implantation. It also depends on the release of free radicals the length and features of incision,the surgical technique used . The risk of endothelial cell density loss is further enhanced when surgeons have to deal with high density cataract, shallow anterior chamber and old age.
Since the time Kelman introduced his technique of phacoemulsification, there has been constant and conscious effort on the part of phaco surgeons to reduce their phaco time by bringing some alteration or innovation in their personal technique or introducing new technologies for the procedure of phacoemulsification. Development of Laser emulsifier, SONAAR machines, introduction of cold phaco with modulations of ultrasound in the form of pulse, micropulse and bursts were achievements towards attaining this end and goal.
Coaxial microphacoemulsification is the standard phacoemulsification technique being practised globally for cataract extraction and on many occasions we intentionally do not use the phaco power either at all or fully as per the pre set limit. In fact the use of efficient fluidic controls and a chopper minimizes the use of phaco energy. If we could assess a zero/minimal ultrasound technique in a scientific setting we might achieve the desired goal without resorting to major modifications of instrumentation and machine. Coaxial MICS fully utilizes the advantages of small incision and provides the most comfortable platform for the surgeons using conventional phacoemulsification.
We imagined that most ideal setting would be introducing zero phaco power in the anterior chamber for emulsifying the nucleus as has been done already in case of Aqualase using warm fluid based system and Howard Fines new technique of mechanically emulsifying the lens with rotators(under investigation). For that we undertook a pilot study in 10 patients and performed coaxial microincision phacoemulsification, introducing the ultrasound power in incremental fashion during the surgery in each of the 10 patients till we could achieve the adequate aspiration of fluid and fragments .
At zero power the phacotip and tubing experienced repeated blockages with associated prolongation of surgical time,thus increment to one percent was made during the same sitting. To our surprise, the very first step of introducing 1% ultrasound power made all the difference.No further increments were required as all techniques of nuclear management and lens aspiration were conveniently possible at this setting.
The procedure of aspiration of fragments was smooth and continuous, it also caused a reduction in the surgical time in comparison to zero power phaco.The cases revealed less corneal endothelial trauma in comparison to conventional phacoemulsification using higher power settings. The most surprising observation was that we could dissemble the nucleus with any known technique of nucleus fragmentation(stop and chop, divide and conquer, phaco-chop) in almost all grades of cataracts .Possibly that high vaccum 300-350 is responsible for this nuclear fragmentation and not only the cavitational effects of ultrasound power.
Keeping all the other parameters uniform we wish to design an RCT to study the effect of eliminating phaco power. With this in view,this study compares the endothelial status in addition to various complications and visual outcome following standard coaxial microincision cataract surgery and coaxial microincision cataract surgery using 1% ultrasound.
- Conditions
- Cataract
- Being tested
- one percent ultrasound power in CMICS, 40 percent ultrasound power in CMICS
- Keywords
- cataract,, phacoemulsification,, one percent ultrasound, endothelial cell density
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
one percent ultrasound power in CMICSProcedure or surgery
Also called OCTOPUS
Co-axial MICS shall be performed in cases allocated to this arm .The ultrasound power shall be kept at one percent during the surgery.A note of effective phacotime,volume of fluid aspirated and any intraoperative complications shall be made.
40 percent ultrasound power in CMICSProcedure or surgery
Also called standard CMICS
Co-axial MICS shall be performed in cases allocated to this arm .The ultrasound power shall be kept at 40 percent during the surgery.A note of effective phacotime,volume of fluid aspirated and any intraoperative complications shall be made.
| Study group | Role | What they receive |
|---|---|---|
| one percent ultrasound | Experimental | Co-axial MICS shall be performed in cases allocated to this arm .The ultrasound power shall be kept at one percent during the surgery.A note of effective phacotime,volume of fluid aspirated and any intraoperative complications shall be made. Receives: Procedure: one percent ultrasound power in CMICS |
| 40 percent ultrasound | Active comparator | Co-axial MICS shall be performed in cases allocated to this arm .The ultrasound power shall be kept at 40 percent during the surgery.A note of effective phacotime,volume of fluid aspirated and any intraoperative complications shall be made. Receives: Procedure: 40 percent ultrasound power in CMICS |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in endothelial cell count from baseline over time
Noncontact specular microscope (EM - 3000; TOMEY: VERSION 2A/OJ) will be used to calculate the endothelial cell density, coefficient of variation of cell size, percentage of hexagonal cells and corneal thickness before surgery and 1day, 1 week, 1, 3, 6, 9 and 12 months visits after surgery. 3 endothelial cell photographs will be taken at each visit and the mean cell count of three photographs will be calculated. Counts will be performed by an observer blinded to which procedure the patient had undergone. Endothelial cell loss will be calculated as a percentage of pre operative cell density
Measured: 1 day,1week,months 1,3,6,9,12
Secondary outcomes (3)
change in Intraocular pressure from baseline
Intraocular pressure will be measured using applanation tonometer.
Measured: 1day,1week,months1,3,6,9,12
visual acuity
snellens visual acuity will be converted to Logmar scale and recorded with and without spectacle correction
Measured: 1 month
posterior capsular rupture
any incidence of posterior capsular rupture during surgery would be noted
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.
- First posted14 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionApr 2011 (estimated)
- Study completionApr 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Ram Manohar Lohia Hospital
- Sponsor type
- Other government
- Investigators
- Taru Dewan, MS FRCSEd, Principal investigator, Dr. R.M.L.Hospital,New Delhi,India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01259349
- Sponsor's protocol ID
- RMLH-002-EYE
- Acronym
- OCTOPUS
- Status last verified
- Nov 2010
- First submitted
- 6 Dec 2010
- Last updated
- 15 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard Coaxial Microincision Cataract Surgery Versus Coaxial Microincision Cataract Surgery Using 1% Ultrasound in Immature Senile Cataract :a Corneal Endothelium Study
- ClinicalTrials.gov ID
- NCT01259349
- Acronym / sponsor ID
- OCTOPUS / RMLH-002-EYE
- Conditions
- Cataract
- Keywords
- cataract,, phacoemulsification,, one percent ultrasound, endothelial cell density
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Dr. Ram Manohar Lohia HospitalOther government
- Study start
- Nov 2010
- Primary completion
- Apr 2011 (estimated)
- Study completion
- Apr 2012 (estimated)
- First posted
- 14 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Coaxial microincision cataract surgery using 1% ultrasound is not inferior to standard coaxial microincision cataract surgery in patients of grade 0.1-6.0 immature senile cataract in terms of corneal endothelial safety.
Detailed description
Corneal endothelial damage and posterior capsular rupture are two most undesirable complications of cataract surgery, infact significant loss of endothelium can lead to corneal decompensation and loss of corneal clarity. However, some degree of endothelial cell loss is inevitable after any cataract surgery. A loss of 3.2%-23.2% has been shown in various studies since 1967. It is well known that during cataract surgery many different factors can generate endothelial damages, these include the impact of the nuclear fragments, the turbulence generated in anterior chamber and the volume of liquid. It is also related to the amount of ultrasonic energy used and the subsequent temperature rise, the contact with surgical instruments and the IOL during implantation. It also depends on the release of free radicals the length and features of incision,the surgical technique used . The risk of endothelial cell density loss is further enhanced when surgeons have to deal with high density cataract, shallow anterior chamber and old age.
Since the time Kelman introduced his technique of phacoemulsification, there has been constant and conscious effort on the part of phaco surgeons to reduce their phaco time by bringing some alteration or innovation in their personal technique or introducing new technologies for the procedure of phacoemulsification. Development of Laser emulsifier, SONAAR machines, introduction of cold phaco with modulations of ultrasound in the form of pulse, micropulse and bursts were achievements towards attaining this end and goal.
Coaxial microphacoemulsification is the standard phacoemulsification technique being practised globally for cataract extraction and on many occasions we intentionally do not use the phaco power either at all or fully as per the pre set limit. In fact the use of efficient fluidic controls and a chopper minimizes the use of phaco energy. If we could assess a zero/minimal ultrasound technique in a scientific setting we might achieve the desired goal without resorting to major modifications of instrumentation and machine. Coaxial MICS fully utilizes the advantages of small incision and provides the most comfortable platform for the surgeons using conventional phacoemulsification.
We imagined that most ideal setting would be introducing zero phaco power in the anterior chamber for emulsifying the nucleus as has been done already in case of Aqualase using warm fluid based system and Howard Fines new technique of mechanically emulsifying the lens with rotators(under investigation). For that we undertook a pilot study in 10 patients and performed coaxial microincision phacoemulsification, introducing the ultrasound power in incremental fashion during the surgery in each of the 10 patients till we could achieve the adequate aspiration of fluid and fragments .
At zero power the phacotip and tubing experienced repeated blockages with associated prolongation of surgical time,thus increment to one percent was made during the same sitting. To our surprise, the very first step of introducing 1% ultrasound power made all the difference.No further increments were required as all techniques of nuclear management and lens aspiration were conveniently possible at this setting.
The procedure of aspiration of fragments was smooth and continuous, it also caused a reduction in the surgical time in comparison to zero power phaco.The cases revealed less corneal endothelial trauma in comparison to conventional phacoemulsification using higher power settings. The most surprising observation was that we could dissemble the nucleus with any known technique of nucleus fragmentation(stop and chop, divide and conquer, phaco-chop) in almost all grades of cataracts .Possibly that high vaccum 300-350 is responsible for this nuclear fragmentation and not only the cavitational effects of ultrasound power.
Keeping all the other parameters uniform we wish to design an RCT to study the effect of eliminating phaco power. With this in view,this study compares the endothelial status in addition to various complications and visual outcome following standard coaxial microincision cataract surgery and coaxial microincision cataract surgery using 1% ultrasound.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| one percent ultrasound | Experimental | Procedure: one percent ultrasound power in CMICSCo-axial MICS shall be performed in cases allocated to this arm .The ultrasound power shall be kept at one percent during the surgery.A note of effective phacotime,volume of fluid aspirated and any intraoperative complications shall be made. |
| 40 percent ultrasound | Active comparator | Procedure: 40 percent ultrasound power in CMICSCo-axial MICS shall be performed in cases allocated to this arm .The ultrasound power shall be kept at 40 percent during the surgery.A note of effective phacotime,volume of fluid aspirated and any intraoperative complications shall be made. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients of >40yrs will be included in the study.
- Grade 0.1-6.0 (LOCS III grading) of senile cataract.
Key exclusion criteria (5 listed)
- Patients with pre-operative endothelial cell density count less than 1500cells/mm2.
- All eye pathologies that can compromise the visual recovery.
- Eyes with any kind of corneal dystrophy or corneal scars preventing visualisation of cataract for reliable grading.
- Raised intraocular pressure (> 21 mmHg).
- Previous intraocular surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| one percent ultrasound power in CMICSAlso: OCTOPUSCo-axial MICS shall be performed in cases allocated to this arm .The ultrasound power shall be kept at one percent during the surgery.A note of effective phacotime,volume of fluid aspirated and any intraoperative complications shall be made. | Procedure or surgery | one percent ultrasound |
| 40 percent ultrasound power in CMICSAlso: standard CMICSCo-axial MICS shall be performed in cases allocated to this arm .The ultrasound power shall be kept at 40 percent during the surgery.A note of effective phacotime,volume of fluid aspirated and any intraoperative complications shall be made. | Procedure or surgery | 40 percent ultrasound |
Primary outcome
change in endothelial cell count from baseline over time
Time frame: 1 day,1week,months 1,3,6,9,12
Noncontact specular microscope (EM - 3000; TOMEY: VERSION 2A/OJ) will be used to calculate the endothelial cell density, coefficient of variation of cell size, percentage of hexagonal cells and corneal thickness before surgery and 1day, 1 week, 1, 3, 6, 9 and 12 months visits after surgery. 3 endothelial cell photographs will be taken at each visit and the mean cell count of three photographs will be calculated. Counts will be performed by an observer blinded to which procedure the patient had undergone. Endothelial cell loss will be calculated as a percentage of pre operative cell density
3 secondary outcomes
change in Intraocular pressure from baseline
Time frame: 1day,1week,months1,3,6,9,12
visual acuity
Time frame: 1 month
posterior capsular rupture
Time frame: day 0 of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2010.
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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.
Taru Dewan, MS FRCSEd 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?
A Phase 3 study testing one percent ultrasound power in CMICS and 40 percent ultrasound power in CMICS in people with 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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 15 Dec 2010. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Taru Dewan, MS FRCSEd (0091-9810673180, tarudewan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in endothelial cell count from baseline over time (time frame: 1 day,1week,months 1,3,6,9,12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Dec 2010; AzTrials last refreshed its copy on 8 Nov 2026.