- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06974578
Comparative Study of Capsular Tension Rings With Hydrophilic vs. Hydrophobic IOLs in Cataract Surgery
This clinical trial investigates the outcomes of routine insertion of capsular tension rings (CTRs) combined with either hydrophilic or hydrophobic intraocular lenses (IOLs) following phacoemulsification for cataract extraction. The study aims to compare visual acuity improvements and refractive outcomes between these two approaches in adult patients with significant cataracts.
Background: Phacoemulsification with IOL implantation remains the gold standard for cataract surgery, but debate persists regarding optimal IOL materials and the value of routine CTR use. While CTRs are established for cases with zonular weakness, their benefits in standard procedures require further evaluation.
Study Design: This randomized, open-label trial will enroll 40 participants aged 40-80 years divided into two groups:
- Group A: Receives CTR with hydrophilic IOL implantation
- Group B: Receives hydrophobic IOL alone
Key Measurements: Researchers will assess:
- Best-corrected visual acuity (BCVA) using logMAR scoring at 1, 3, and 6 months post-surgery
- Refractive error measurements (spherical equivalent) during the same follow-up periods
Clinical Significance: The study will provide valuable data on whether routine CTR use offers measurable benefits when paired with different IOL materials, potentially influencing surgical practice standards for cataract procedures. Results may clarify whether the additional step of CTR insertion in standard cases justifies the added surgical time and cost.
Exclusion Criteria: The trial excludes patients with previous ocular surgery, zonular instability requiring CTR, complicated cataracts, or active ocular inflammation/infection to maintain study homogeneity.
Conducted by Benha University, this investigation runs from February through September 2024, offering timely insights into this surgical question.
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