Clinical trial NCT05377515: Evaluation of Visual Outcomes in Patients With Complex Corneas Implanted With the IC-8 IOL
Official title: Evaluation of Visual Outcomes in Patients With Complex Corneas Implanted With the IC-8 IOL
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Presbyopia
Irregular; Contour of Cornea
Lead sponsor: AcuFocus, Inc.
Sponsor class: INDUSTRY
First posted: 2022-05-17
Enrollment: 21
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients for this study will be recruited from patients with complex corneas who have been previously implanted with the IC-8 IOL after cataract removal. Anticipated study sample size of up to 40 patients will be evaluated.

Patients will be screened for eligibility, and an informed consent will be obtained from those who meet the screening criteria and are interested in participating in the study.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Monocular UCDVA
timeFrame: 3 Months
measure: Monocular UCIVA
timeFrame: 3 Months
measure: Monocular UCNVA
timeFrame: 3 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore Eye Research Institute / Singapore National Eye Centre
Study officials:
affiliation: AcuFocus, Inc.
name: Magda Michna, Ph.D.
role: STUDY_DIRECTOR
References: