Clinical trial NCT04499768: A Longitudinal Study of Choroidal Changes After Cataract Surgery in Eyes With Diabetic Retinopathy
Official title: A Longitudinal Study of Choroidal Changes Assessed With Swept-source Optical Coherence Tomography After Cataract Surgery in Eyes With Diabetic Retinopathy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Optical Coherence Tomography
Diabetic Retinopathy
Choroid
Keywords: Diabetic choroidopathy
Diabetic retinopathy
choroidal vascularity index
choroidal thickness
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2020-08-05
Enrollment: 46
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 23 eyes of 23 cataract patients with mild/moderate NPDR without DME, and 23 age-matched non-diabetic patients

Brief summary: To determine the influence of phacoemulsification on choroidal vasculature in patients with diabetic retinopathy (DR) undergoing cataract surgery

Detailed description: To determine the influence of phacoemulsification on choroidal vasculature in patients with diabetic retinopathy (DR) undergoing cataract surgery through the follow-up of choroidal thickness (CT) and choroidal vascularity index (CVI) using swept-source optical coherence tomography (SS-OCT) system.

Eligibility criteria: Inclusion Criteria:

* aged⩾40years; intraocular pressure (IOP) \< 21 mm Hg in both eyes, spherical refractive error\<6 diopters spherical equivalent.

Exclusion Criteria:

* previous retinal surgery, glaucoma, uveitis, age-related macular degeneration, arterial or vein occlusions, macular hole, or other ocular diseases that could interfere the CT and/or CVI measurement, severe systemic diseases, such as uncontrolled hypertension, obstructive sleep apnea, etc.

Primary outcomes:
measure: CVI at baseline
timeFrame: CVI was assessed at baseline(within 1 week before surgery)
measure: CVI at 1 week postoperatively
timeFrame: CVI was assessed 1 week after surgery.
measure: CVI at 1 month postoperatively
timeFrame: CVI was assessed 1 month after surgery.
measure: CVI at 3 months postoperatively
timeFrame: CVI was assessed 3 months after surgery.
measure: CT at baseline
timeFrame: CT was assessed at baseline and 1 week, 1 month, 3 month after surgery.
measure: CT at 1 week postoperatively
timeFrame: CT was assessed at 1 week after surgery.
measure: CT at 1 month postoperatively
timeFrame: CT was assessed at 1 month after surgery.
measure: CT at 3 months postoperatively
timeFrame: CT was assessed at 3 months after surgery.
measure: VD at baseline
timeFrame: VD of the choriocapillaris was assessed at baseline.
measure: VD at 1 week postoperatively
timeFrame: VD of the choriocapillaris was assessed 1 week after surgery.
measure: VD at 1 month postoperatively
timeFrame: VD of the choriocapillaris was assessed 1 month after surgery.
measure: VD at 3 months postoperatively
timeFrame: VD of the choriocapillaris was assessed 3 months after surgery.
Secondary outcomes:
measure: IOP at baseline
timeFrame: IOP was assessed at baseline and 1 week, 1 month, 3 month after surgery.
measure: IOP at 1 week postoperatively
timeFrame: IOP was assessed 1 week after surgery.
measure: IOP at 1 month postoperatively
timeFrame: IOP was assessed 1 month after surgery.
measure: IOP at 3 months postoperatively
timeFrame: IOP was assessed 3 months after surgery.
measure: BCVA at baseline
timeFrame: BCVA was assessed at baseline .
measure: BCVA at 3 months postoperatively
timeFrame: BCVA was assessed 3 months after surgery.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Jiao Tong University School of Medicine
name: Xi Shen, PhD
role: STUDY_DIRECTOR
References:
citation: Yao H, Gao S, Liu X, Zhou Y, Cheng Y, Shen X. Choroidal Structural Changes Assessed with Swept-Source Optical Coherence Tomography after Cataract Surgery in Eyes with Diabetic Retinopathy. J Ophthalmol. 2020 Oct 29;2020:5839837. doi: 10.1155/2020/5839837. eCollection 2020.