Performance of Two Hydrophobic IOLs

NCT ID: NCT05639049

Last Updated: 2022-12-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2024-11-01

Brief Summary

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

Detailed 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.

Conditions

Cataract

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Enova GF3

Patient will receive the monofocal IOL in one eye during cataract surgery

Group Type: EXPERIMENTAL

Enova GF3

Intervention Type: DEVICE

Enova GF3, monofocal IOL

Tecnis 1-piece ZCB00

Patient will receive the monofocal IOL in one eye during cataract surgery

Group Type: EXPERIMENTAL

Tecnis 1-piece ZCB00

Intervention Type: DEVICE

Tecnis 1-piece ZCB00, monofocal IOL

Interventions

Enova GF3

Enova GF3, monofocal IOL

Intervention Type: DEVICE

Tecnis 1-piece ZCB00

Tecnis 1-piece ZCB00, monofocal IOL

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 105 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vienna Institute for Research in Ocular Surgery

OTHER

Sponsor Role: lead

Responsible Party

Prim. Prof. Dr. Oliver Findl, MBA

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Oliver Findl, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Vienna Institute for Research in Ocular Surgery

Locations

Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna

Vienna, , Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Christoph Spartalis, MD

Role: CONTACT

office@viros.at

01 91021 ext. 57564

Manuel Ruiss, MSc

Role: CONTACT

office@viros.at

01 91021 ext. 57564

Facility Contacts

Oliver Findl, MD, MBA

Role: primary

office@viros.at

+43 91021 ext. 57564

Other Identifiers

Enova

Identifier Type: -

Identifier Source: org_study_id