CataractPhase 4NCT00449267
Aurolab Hydrophobic Foldable Intraocular Lens Study
A Phase 4 study testing Intraocular Lens in people with Cataract, run by Aurolab at 1 site in India.
Trial summary
The purpose of this study is to evaluate whether hydrophobic intraocular lenses manufactured by aurolab are safe and effective in the surgical treatment of cataract. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Cataract
- What is being tested?
- Intraocular Lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIndia
- Study dates
- Mar 2007to Dec 2007
- Phase
- Phase 4
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40 to 65 years
- Senile Cataract
- Posterior Subcapsular Cataract (PSCC)
Who cannot join
- Obviously debilitated patients
- Cardiac and other serious illness
- Diabetic Patients
- Traumatic cataract
- Complicated cataract
- Congenital cataract
Show all 18Show fewer
- Drug induced cataract
- Shallow anterior chamber
- Poor mydriasis
- Amblyopia
- Pseudo exfoliation (PXF)
- Dense posterior polar cataract (PPC)
- One eyed patients
- Glaucoma
- Uveitis
- Corneal Pathology
- Retinal Pathology
- Intra operative complications like PC rupture, Zonular dialysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Hydrophobic Foldable Intraocular Lenses
The purpose of this study is to evaluate whether hydrophobic intraocular lenses manufactured by aurolab are safe and effective in the surgical treatment of cataract.
Read the detailed description
Hydrophobic as the name suggests is fear for water. Hydrophobic foldable IOLs are made from acrylic material. Aurolab has developed its own hydrophobic acrylic material. This material has been subjected to several biocompatibility studies and it has proved itself to be biocompatible.
- Conditions
- Cataract
- Being tested
- Intraocular Lens
- Keywords
- Lenses, Intraocular, Prospective Studies, Visual acuity, Clinical Trial
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraocular LensDevice
Also called Aurovue, Model HP757SQ
Phacoemulsification with in the bag implantation of the IOL
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Device: Intraocular Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Measured: 10days, 40 days, 150 days post operatively
Secondary outcomes (14)
Refraction
Measured: 10days, 40 days, 150 days post operatively
Intraocular pressure
Measured: 10days, 40 days, 150 days post operatively
Corneal status
Measured: 10days, 40 days, 150 days post operatively
Iritis
Measured: 10days, 40 days, 150 days post operatively
IOL decentration
Measured: 10days, 40 days, 150 days post operatively
IOL tilt
Measured: 10days, 40 days, 150 days post operatively
IOL discoloration
Measured: 10days, 40 days, 150 days post operatively
IOL opacity
Measured: 10days, 40 days, 150 days post operatively
Cystoid macular oedema
Measured: 10days, 40 days, 150 days post operatively
Hypopyon
Measured: 10days, 40 days, 150 days post operatively
Endophthalmitis
Measured: 10days, 40 days, 150 days post operatively
Pupillary block
Measured: 10days, 40 days, 150 days post operatively
Retinal detachment
Measured: 10days, 40 days, 150 days post operatively
Status of anterior and posterior capsule
Measured: 10days, 40 days, 150 days post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2007 (estimated)
- Study startMar 2007
- Primary completionDec 2007
- Study completionDec 2007
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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aurolab
- Sponsor type
- University, hospital or other
- Investigators
- Haripriya Aravind, MBBS, MS, Principal investigator, Aravind Eye Hospital, Madurai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00449267
- Sponsor's protocol ID
- 1PN1010614
- Status last verified
- Feb 2009
- First submitted
- 17 Mar 2007
- Last updated
- 11 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Hydrophobic Foldable Intraocular Lenses
- ClinicalTrials.gov ID
- NCT00449267
- Acronym / sponsor ID
- 1PN1010614
- Conditions
- Cataract
- Keywords
- Lenses, Intraocular, Prospective Studies, Visual acuity, Clinical Trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- AurolabUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 20 Mar 2007 (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.
The purpose of this study is to evaluate whether hydrophobic intraocular lenses manufactured by aurolab are safe and effective in the surgical treatment of cataract.
Detailed description
Hydrophobic as the name suggests is fear for water. Hydrophobic foldable IOLs are made from acrylic material. Aurolab has developed its own hydrophobic acrylic material. This material has been subjected to several biocompatibility studies and it has proved itself to be biocompatible.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Intraocular Lens |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 40 to 65 years
- Senile Cataract
- Posterior Subcapsular Cataract (PSCC)
Key exclusion criteria (18 listed)
- Obviously debilitated patients
- Cardiac and other serious illness
- Diabetic Patients
- Traumatic cataract
- Complicated 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 |
|---|---|---|
| Intraocular LensAlso: Aurovue, Model HP757SQPhacoemulsification with in the bag implantation of the IOL | Device | 1 |
Primary outcome
Visual acuity
Time frame: 10days, 40 days, 150 days post operatively
14 secondary outcomes
Refraction
Time frame: 10days, 40 days, 150 days post operatively
Intraocular pressure
Time frame: 10days, 40 days, 150 days post operatively
Corneal status
Time frame: 10days, 40 days, 150 days post operatively
Iritis
Time frame: 10days, 40 days, 150 days post operatively
IOL decentration
Time frame: 10days, 40 days, 150 days post operatively
IOL tilt
Time frame: 10days, 40 days, 150 days post operatively
IOL discoloration
Time frame: 10days, 40 days, 150 days post operatively
IOL opacity
Time frame: 10days, 40 days, 150 days post operatively
Cystoid macular oedema
Time frame: 10days, 40 days, 150 days post operatively
Hypopyon
Time frame: 10days, 40 days, 150 days post operatively
Endophthalmitis
Time frame: 10days, 40 days, 150 days post operatively
Pupillary block
Time frame: 10days, 40 days, 150 days post operatively
Retinal detachment
Time frame: 10days, 40 days, 150 days post operatively
Status of anterior and posterior capsule
Time frame: 10days, 40 days, 150 days post operatively
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 11 Feb 2009.
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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.
Haripriya Aravind, MBBS, MS principal investigator
Aravind Eye Hospital, Madurai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intraocular Lens in people with Cataract, run by Aurolab 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 3 inclusion and 18 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 11 Feb 2009. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Visual acuity (time frame: 10days, 40 days, 150 days post operatively). 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 11 Feb 2009.