Intraoperative Performance and Postoperative Outcomes Following Cataract SurgeryNCT01664689
Intraoperative and Postoperative Outcomes of Three Ophthalmic Viscosurgical Devices During Phacoemulsification
A study testing Microcoaxial Phacoemulsification in people with Intraoperative Performance and Postoperative Outcomes Following Cataract Surgery, run by Iladevi Cataract and IOL Research Center at 1 site in India.
Trial summary
Ophthalmic Viscosurgical Devices (OVDs) play a crucial role during phacoemulsification, by providing endothelial protection, maintaining space, as well as facilitating surgical maneuvers, including IOL implantation. Equally important is the ease of use, good visualisation and easy removal of the OVD from the eye. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Intraoperative Performance and Postoperative Outcomes Following Cataract Surgery
- What is being tested?
- Microcoaxial Phacoemulsification
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIndia
- Study dates
- Oct 2011to Mar 2012
- Phase
- Interventional
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age related, uncomplicated senile cataracts
Who cannot join
- presence of glaucoma,
- shallow anterior chamber (ACD < 2.1mm),
- pupillary dilatation < 6mm,
- extremely dense cataracts,
- posterior polar cataract,
- subluxated cataract,
Show all 11Show fewer
- white mature cataract,
- diabetic retinopathy,
- high myopia (defined as AL > 25mm),
- uveitis, or
- previous ocular trauma/surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Ophthalmic Viscosurgical Devices (OVDs) play a crucial role during phacoemulsification, by providing endothelial protection, maintaining space, as well as facilitating surgical maneuvers, including IOL implantation. Equally important is the ease of use, good visualisation and easy removal of the OVD from the eye. Currently, 3 popularly used OVDs as a single injection sufficing for surgery are: Healon 5, DiscoVisc, and Celoftal (2% hydroxypropylmethylcellulose). Whereas, there are studies showing efficacy of each of these in clinical scenarios, there is no randomized trial comparing intraoperative performance and postoperative outcomes. The aim of this study was to compare intraoperative performance and postoperative outcomes following microcoaxial phacoemulsification when using one of the three OVDs
- Being tested
- Microcoaxial Phacoemulsification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microcoaxial PhacoemulsificationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| DiscoVisc | Active comparator | microcoaxial phacoemulsification performed with discovisc Receives: Procedure: Microcoaxial Phacoemulsification |
| Healon 5 | Active comparator | microcoaxial phacoemulsification using healon 5 Receives: Procedure: Microcoaxial Phacoemulsification |
| Celoftal | Active comparator | microcoaxial phacoemulsification using celoftal Receives: Procedure: Microcoaxial Phacoemulsification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal clarity on postoperative day 1
Measured: postoperative day 1
Secondary outcomes (1)
Central corneal thickness on postoperative day 1 and week 1
Measured: day 1 and week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2012 (estimated)
- Study startOct 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative Performance and Postoperative Outcomes Following Cataract SurgeryStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iladevi Cataract and IOL Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01664689
- Sponsor's protocol ID
- OVD12
- Status last verified
- Aug 2012
- First submitted
- 10 Aug 2012
- Last updated
- 14 Aug 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative and Postoperative Outcomes of Three Ophthalmic Viscosurgical Devices During Phacoemulsification
- ClinicalTrials.gov ID
- NCT01664689
- Acronym / sponsor ID
- OVD12
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Iladevi Cataract and IOL Research CenterUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 14 Aug 2012 (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.
Ophthalmic Viscosurgical Devices (OVDs) play a crucial role during phacoemulsification, by providing endothelial protection, maintaining space, as well as facilitating surgical maneuvers, including IOL implantation. Equally important is the ease of use, good visualisation and easy removal of the OVD from the eye. Currently, 3 popularly used OVDs as a single injection sufficing for surgery are: Healon 5, DiscoVisc, and Celoftal (2% hydroxypropylmethylcellulose). Whereas, there are studies showing efficacy of each of these in clinical scenarios, there is no randomized trial comparing intraoperative performance and postoperative outcomes. The aim of this study was to compare intraoperative performance and postoperative outcomes following microcoaxial phacoemulsification when using one of the three OVDs
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DiscoVisc | Active comparator | Procedure: Microcoaxial Phacoemulsificationmicrocoaxial phacoemulsification performed with discovisc |
| Healon 5 | Active comparator | Procedure: Microcoaxial Phacoemulsificationmicrocoaxial phacoemulsification using healon 5 |
| Celoftal | Active comparator | Procedure: Microcoaxial Phacoemulsificationmicrocoaxial phacoemulsification using celoftal |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age related, uncomplicated senile cataracts
Key exclusion criteria (11 listed)
- presence of glaucoma,
- shallow anterior chamber (ACD < 2.1mm),
- pupillary dilatation < 6mm,
- extremely dense cataracts,
- posterior polar cataract,
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 |
|---|---|---|
| Microcoaxial Phacoemulsification | Procedure or surgery | Celoftal, DiscoVisc, Healon 5 |
Primary outcome
Corneal clarity on postoperative day 1
Time frame: postoperative day 1
1 secondary outcome
Central corneal thickness on postoperative day 1 and week 1
Time frame: day 1 and week 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2012.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microcoaxial Phacoemulsification in people with Intraoperative Performance and Postoperative Outcomes Following Cataract Surgery, run by Iladevi Cataract and IOL Research Center 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 11 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 14 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Corneal clarity on postoperative day 1 (time frame: postoperative day 1). 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 14 Aug 2012.