Evaluation of Visual Outcomes in Patients With Complex Corneas Implanted With the IC-8 IOL

Cataract Clinical Trial

Official title:

Evaluation of Visual Outcomes in Patients With Complex Corneas Implanted With the IC-8 IOL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05377515
• Other study ID #: IC8-303-EXPA
• Status: Completed
• Start date: February 10, 2022
• Est. completion date: December 30, 2022

Study information

• Verified date: May 2023
• Source: AcuFocus, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of this study is to evaluate visual outcomes in patients with complex corneas who have been previously implanted with the IC-8 IOL after cataract removal.

Description:

This will be a prospective, non-randomized, single-arm, single-visit, single-center, clinical study in up to 40 patients previously contralaterally implanted with the IC-8 IOL at one clinical site in Singapore.

The purpose of this study is to to evaluate visual outcomes in patients with complex corneas who have been previously implanted with the IC-8 IOL after cataract removal. The co-primary study endpoints are monocular uncorrected distance, intermediate, near visual acuities.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

1. Minimum 22 years of age;

2. Able to comprehend and have signed a statement of informed consent;

3. Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visit(s);

4. Having complex corneas prior to cataract surgery;

5. Previous cataract surgery and IC-8 IOL implantation in the eye (implanted for 3 months or longer prior to study participation).

Exclusion Criteria:

1. Baseline visual acuity worse than 20/25 BCDVA in either eye;

2. Presence of ocular abnormalities or conditions other than corneal irregularities that could confound the study outcome(s), such as:

1. Strabismus or amblyopia

2. Retinal or macular abnormalities

3. Recurrent and/or persistent ocular inflammation

4. Known pathology that may affect visual acuity to a level worse than 20/25 BCDVA

3. Previous intraocular surgery, except cataract surgery, pterygium surgery, or corneal procedures (other than corneal-cross linking);

4. Previous corneal cross-linking procedure with any corneal haze;

5. Conditions requiring planned ocular surgical intervention, except Nd:YAG capsulotomy;

6. Severe dry eye or other conditions (such as hormonal fluctuations) that could lead to unstable refraction and/or visual acuity measurements or eye discomfort even with ocular lubricants or dry eye medication;

7. Patient is pregnant or nursing.

Related Conditions & MeSH terms

• Cataract
• Corneal Diseases
• Irregular; Contour of Cornea
• Presbyopia

Locations

Country	Name	City	State
Singapore	Singapore Eye Research Institute / Singapore National Eye Centre	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
AcuFocus, Inc.

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Monocular UCDVA	0.3 logMAR or better	3 Months
Primary	Monocular UCIVA	0.3 logMAR or better	3 Months
Primary	Monocular UCNVA	not worse than 0.3 logMAR	3 Months