Bilateral CataractISBCSNCT01841957
Immediate Simultaneous Bilateral Cataract Surgery
A study testing ISBCS and DSBCS in people with Bilateral Cataract, run by Sloan W. Rush, MD at 1 site in United States.
Trial summary
To evaluate the safety and efficacy of treating visually significant bilateral cataract with the newer technique of Immediate Simultaneous Bilateral Cataract Surgery (ISBCS) versus the conventional technique of Delayed Sequential Bilateral Cataract Surgery (DSBCS) in a select patient population. Read more about this study
- Who is it for?
- Ages 30 to 100 years
- Conditions the study is for
- Bilateral Cataract
- What is being tested?
- ISBCS and DSBCS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to 1 Apr 2022
- 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 30 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 30-100
- Candidate for topical anesthesia
- Signed the informed consents
Who cannot join
- Allergies to medications used in study
- Cannot have topical anesthesia
- Unwilling to participate in research trial
- Have any other significant ocular comorbidities
- Have known systemic immuno-compromised state
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate Simultaneous Bilateral Cataract Surgery: A Prospective, Case-controlled Clinical Trial in the United States
To evaluate the safety and efficacy of treating visually significant bilateral cataract with the newer technique of Immediate Simultaneous Bilateral Cataract Surgery (ISBCS) versus the conventional technique of Delayed Sequential Bilateral Cataract Surgery (DSBCS) in a select patient population.
- Conditions
- Bilateral Cataract
- Being tested
- ISBCS, DSBCS
- Keywords
- Bilateral Cataract, Simultaneous Cataract Surgery, ISBCS
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ISBCSProcedure or surgery
same-day cataract surgery
DSBCSProcedure or surgery
bilateral surgery delayed by 1-3 weeks amongst eyes
| Study group | Role | What they receive |
|---|---|---|
| ISBCS | Experimental | Immediate Simultaneous Bilateral Cataract Surgery Receives: Procedure: ISBCS |
| DSBCS | Active comparator | Delayed Sequential Bilateral Cataract Surgery Receives: Procedure: DSBCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Best uncorrected and best spectacle corrected post-operative visual acuity
Measured: 3 weeks
Secondary outcomes (1)
Recovery time and number of post-operative visits
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2013 (estimated)
- Study startApr 2013
- Primary completion1 Apr 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bilateral 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sloan W. Rush, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sloan W. Rush, MD, Panhandle Eye Group, LLP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01841957
- Sponsor's protocol ID
- 2
- Acronym
- ISBCS
- Status last verified
- Apr 2022
- First submitted
- 18 Apr 2013
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Simultaneous Bilateral Cataract Surgery: A Prospective, Case-controlled Clinical Trial in the United States
- ClinicalTrials.gov ID
- NCT01841957
- Acronym / sponsor ID
- ISBCS / 2
- Conditions
- Bilateral Cataract
- Keywords
- Bilateral Cataract, Simultaneous Cataract Surgery, ISBCS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sloan W. Rush, MDUniversity, hospital or other
- Study start
- Apr 2013 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 29 Apr 2013 (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.
To evaluate the safety and efficacy of treating visually significant bilateral cataract with the newer technique of Immediate Simultaneous Bilateral Cataract Surgery (ISBCS) versus the conventional technique of Delayed Sequential Bilateral Cataract Surgery (DSBCS) in a select patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ISBCS | Experimental | Procedure: ISBCSImmediate Simultaneous Bilateral Cataract Surgery |
| DSBCS | Active comparator | Procedure: DSBCSDelayed Sequential Bilateral Cataract Surgery |
Who may qualify
- Ages
- 30 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 30-100
- Candidate for topical anesthesia
- Signed the informed consents
Key exclusion criteria (5 listed)
- Allergies to medications used in study
- Cannot have topical anesthesia
- Unwilling to participate in research trial
- Have any other significant ocular comorbidities
- Have known systemic immuno-compromised state
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 |
|---|---|---|
| ISBCSsame-day cataract surgery | Procedure or surgery | ISBCS |
| DSBCSbilateral surgery delayed by 1-3 weeks amongst eyes | Procedure or surgery | DSBCS |
Primary outcome
Visual acuity
Time frame: 3 weeks
Best uncorrected and best spectacle corrected post-operative visual acuity
1 secondary outcome
Recovery time and number of post-operative visits
Time frame: 6 months
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 28 Apr 2022.
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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.
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 ISBCS and DSBCS in people with Bilateral Cataract, run by Sloan W. Rush, MD at 1 site in United States.
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 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: finished, as of the sponsor's last update on 28 Apr 2022. 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 United States. 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?
Visual acuity (time frame: 3 weeks). 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 28 Apr 2022.