Bilateral Cataract Clinical Trial
— ISBCSOfficial title:
Immediate Simultaneous Bilateral Cataract Surgery: A Prospective, Case-controlled Clinical Trial in the United States
| NCT number | NCT01841957 |
| Other study ID # | 2 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | April 2013 |
| Est. completion date | April 1, 2022 |
| Verified date | April 2022 |
| Source | Panhandle Eye Group, LLP |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 100 |
| Est. completion date | April 1, 2022 |
| Est. primary completion date | April 1, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 30 Years to 100 Years |
| Eligibility | Inclusion Criteria: - Age 30-100 - Candidate for topical anesthesia - Signed the informed consents Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Panhandle Eye Group | Amarillo | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Sloan W. Rush, MD |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Visual acuity | Best uncorrected and best spectacle corrected post-operative visual acuity | 3 weeks | |
| Secondary | Recovery time and number of post-operative visits | 6 months |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03861351 -
Non-comparative Trial Following Participants Implanted Bilaterally With Mini WELL Toric Ready Intraocular Lens for 6 Months After the Second Eye Implant (FUSION)
|
N/A | |
| Completed |
NCT03400124 -
Cost-effectiveness of ISBCS vs. DSBCS
|
N/A | |
| Completed |
NCT05604781 -
Symfony/Synergy IOL Combination Outcomes
|
||
| Completed |
NCT02734459 -
A Bioequivalence Study to Compare the Pharmacokinetics (PK) Of Marketed Product TobraDex® To An Experimental Ophthalmic Sterile Ointment Containing Tobramycin And Dexamethasone In Aqueous Humor In Patients Undergoing Indicated Cataract Surgery
|
Phase 3 | |
| Not yet recruiting |
NCT05069753 -
Patient Reported Visual Satisfaction Following Same Day or Delayed Bilateral Cataract Surgery
|
N/A | |
| Completed |
NCT02042755 -
Pilot Study With a Diffractive Trifocal IOL (POD AY 26P FineVision)
|
||
| Recruiting |
NCT05832749 -
Comparison of the Safety and Efficacy of Ophtesis Bio 3% With a Similar 3% Sodium Hyaluronate OVD
|