Performance of Two Hydrophobic IOLs

Cataract Clinical Trial

Official title:

Capsular Bag Performance of Two Hydrophobic Intraocular Lenses of Different Design

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05639049
• Other study ID #: Enova
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: November 1, 2024

Study information

• Verified date: November 2022
• Source: Vienna Institute for Research in Ocular Surgery
• Contact: Christoph Spartalis, MD
• Phone: 01 91021
• Email: office[@]viros.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comparison of the capsular bag performance of two hydrophobic intraocular lenses of different design.

Description:

Continuous improvements in cataract surgery technique, intraocular lens (IOL) materials, and design over the past few decades, have led to a more safe procedure with satisfactory refractive outcomes and a short rehabilitation time. By that, patients' expectations concerning their postoperative visual quality and refractive outcome are increasing. However, two main problems might occur after cataract surgery: instability of the IOL position in the capsular bag and formation of posterior capsule opacification (PCO). Both may decrease the optical performance of an IOL.

The performance of an IOL depends on its behaviour in the capsular bag, which has an influence on the anterior chamber depth (ACD), as well as the postoperative refractive shift, the tilt and decentration of the IOL. Several factors such as IOL design and material, capsulorhexis size, capsular bag diameter, and capsular fibrosis or shrinkage may lead to a suboptimal IOL position. Misalignment of an IOL away from the retina leads to a myopic shift, while towards the retina leads to a hyperopic outcome. This explains why inaccurate prediction of postoperative ACD remains the main source of error in IOL power calculation.

One main goal of modern cataract surgery is to yield a low and predictable ACD shift as well as low degrees of IOL tilt and decentration after surgery in order to achieve ideal optical performance of the IOL.

Another aspect of capsular bag performance of an IOL is posterior capsule opacification (PCO). PCO is one of the most frequent long-term complications after cataract surgery leading to dissatisfying results by decreased visual function. Source of PCO are lens epithelial cells from the equator of the lens capsule, which acquire the ability to migrate and proliferate, causing epithelial ingrowth between the IOL and the posterior capsule. It is estimated that PCO occurs at a rate of 12% one year, 21% three years, and 28% five years after cataract surgery. PCO can be treated with neodymium-doped yttrium aluminium garnet (Nd:YAG) laser capsulotomy. However, complications including an increase in intraocular pressure, ocular inflammation, cystoid macular edema, and retinal detachment may occur after this treatment. Hence lower rates of PCO would improve patients long term safety following cataract surgery. Moreover, it would increase patient satisfaction.

The material and design of an IOL may have an effect on the formation of PCO. Sharp optic edge design has been shown to be a major factor in the prevention of PCO. Furthermore, acrylic and silicone hydrophobic materials showed a lower risk for PCO formation and lower rates of postoperative Nd:YAG laser capsulotomy than hydrophilic IOLs.

In this study the ACD shift and IOL tilt and centration as well as the PCO formation of an IOL with a new design, the Enova GF3 IOL will be compared to a standard monofocal IOL, the Tecnis 1-piece ZCB00.

90 eyes of 45 patients will be included into this study. According to the randomization, the ENOVA GF3 will be implanted in one eye and the ZCB00 in the fellow eye of each patient. Follow-up visits will take place 1 week, 3 months, 6 months, and 12 months after the surgery. At each visit a slitlamp examination, non-contact intraocular pressure measurement, refraction, visual acuity testing, biometry, retroillumination photography, and purkinjemeter assessments will be performed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: November 1, 2024
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 105 Years

Eligibility

Inclusion Criteria:

• Age-related bilateral cataract

• Age 21 or older

• Visual acuity > 0.05

• Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant

• Written informed consent prior to surgery

Exclusion Criteria:

• Relevant other ophthalmic diseases such as pseudoexfoliation syndrome (PEX), traumatic cataract, intraoperative Floppy Iris Syndrome (IFIS), or other co-morbidities that could affect capsular bag stability (e.g. Marfan syndrome)

• Any ophthalmic comorbidity that may compromise visual function or create problems with measurements (e.g. macular degeneration, amblyopia, corneal scars, etc.)

• Previous ocular surgery or trauma

• Pregnancy (pregnancy test will be taken in women of reproductive age)

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Enova GF3
Enova GF3, monofocal IOL
• Tecnis 1-piece ZCB00
Tecnis 1-piece ZCB00, monofocal IOL

Locations

Country	Name	City	State
Austria	Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Vienna Institute for Research in Ocular Surgery

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anterior chamber depth	Anterior chamber depth will be assessed using a biometry device and will be compared between both monofocal IOLs	24 months
Secondary	IOL tilt	IOL tilt will be assessed using the purkinjemeter and will be compared between both IOLs	24 months
Secondary	Posterior capsule opacification (PCO)	PCO will be assessed using retroillumination photography and will be compared between both groups	24 months
Secondary	Visual acuity	Visual acuity will be assessed in the far and intermediate distance using ETDRS charts and will be compared between both groups	24 months
Secondary	Catquest 9SF questionnaire	The Catquest 9SF questionnaire will be handed out to all patients	24 months