BridgeMD
Compares treatment options for Cataract
Official title A Prospective, Randomized, Subject- and Examiner-Masked, Multicenter Study Comparing Bilateral Clareon TruPlus and Bilateral Clareon Monofocal Intraocular Lens Implantation (Spherical and Toric) in Cataract Subjects
ClinicalTrials.gov ID: NCT07693205
What this study is testing
- What it's testing
- This investigator-initiated trial is a prospective, randomized, parallel-group, bilateral implantation study comparing Clareon TruPlus versus Clareon monofocal intraocular lenses (IOLs). Spherical and toric models are permitted in both arms based on standardized preoperative planning and clinical indication.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older
You may be able to join if
- Adult cataract patients aged ≥22 years scheduled for cataract surgery in both eyes due to visually significant cataracts.
- Ability to understand and sign an IRB/ethics committee-approved informed consent form.
- Willingness and ability to attend all scheduled study visits as required by the protocol and complete all study testing procedures.
- Postoperative potential visual acuity of 20/25 or better in each eye, as determined by the investigator.
- Preoperative corneal astigmatism that can be corrected with a T3-T5 toric IOL, or with a spherical IOL plus LRIs/Aks, with either resulting in a...
You likely can't join if
- Women who are pregnant, planning to become pregnant during the study period, or breastfeeding (by verbal confirmation).
- Ocular conditions that could confound study results, including moderate-to-severe corneal pathology, irregular astigmatism, moderate-to-severe dry...
- Any form of confirmed glaucomatous optic neuropathy or other optic nerve disease expected to affect visual function outcomes.
- History of amblyopia, monofixation syndrome, or other binocular vision disorder with poor stereopsis that could confound binocular testing.
- Prior ocular surgery (including corneal refractive surgery) in either eye.
- Zonular laxity/dehiscence, pseudoexfoliation with clinically significant zonulopathy, nystagmus, or strabismus that could compromise uncomplicated...
See the full eligibility criteria
- Adult cataract patients aged ≥22 years scheduled for cataract surgery in both eyes due to visually significant cataracts.
- Ability to understand and sign an IRB/ethics committee-approved informed consent form.
- Willingness and ability to attend all scheduled study visits as required by the protocol and complete all study testing procedures.
- Postoperative potential visual acuity of 20/25 or better in each eye, as determined by the investigator.
- Preoperative corneal astigmatism that can be corrected with a T3-T5 toric IOL, or with a spherical IOL plus LRIs/Aks, with either resulting in a predicted postoperative astigmatism \<0.50 D.
- IOL power and, if toric, cylinder availability within labeled ranges for the assigned IOL family.
- Ability to understand and complete study questionnaires.
- Women who are pregnant, planning to become pregnant during the study period, or breastfeeding (by verbal confirmation).
- Ocular conditions that could confound study results, including moderate-to-severe corneal pathology, irregular astigmatism, moderate-to-severe dry eye/ocular surface disease not optimized, preexisting retinal...
- Any form of confirmed glaucomatous optic neuropathy or other optic nerve disease expected to affect visual function outcomes.
- History of amblyopia, monofixation syndrome, or other binocular vision disorder with poor stereopsis that could confound binocular testing.
- Prior ocular surgery (including corneal refractive surgery) in either eye.
- Zonular laxity/dehiscence, pseudoexfoliation with clinically significant zonulopathy, nystagmus, or strabismus that could compromise uncomplicated surgery or reliable visual testing.
- Participation in another clinical study (treatment) that could interfere with study results.
- Planned monovision/mini-monovision or desire for monovision targeting.
- Systemic conditions that may affect healing or visual outcomes (e.g., uncontrolled diabetes mellitus, certain autoimmune disorders) per investigator judgment.
- Psychiatric or cognitive disorders that may impair the ability to comply with study procedures or provide reliable self-assessments.
- Any active ocular infection or inflammation.
The study team makes the final eligibility decision.
Where it's taking place
- Sugar Land, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sugar Land, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.