環狀眼內植入鏡片試驗結果良好


  Oct. 25, 2004 (紐奧良) - 一項針對101位患者進行的先期性試驗顯示,加州Starr Surgical Company所作的環狀眼內植入式鏡片試驗後發現,植入眼後室後的效果良好;這項試驗是為取得美國食品藥物檢驗局核准而進行的。
  
  在2004年美國眼科協會及歐洲眼科協會的聯合會議中,Starr公司的顧問Donald Sanders醫師指出,有82.4%的近視眼患者在6個月內達到20/20以上的視力無需矯正度,有95%達到20/25以上。
  
  Sanders醫師表示,手術前最佳視力矯正度(BCVA)及手術後視力無需矯正度(UCVA)的差別只有1%,平均圓柱屈光矯正度為77%;手術前的圓柱屈光矯正度平均值為1.98D,到第六個月時已經降到0.45D,有五分之一的患者獲得最少2線的BCVA,沒有任何人損失2線以上。
  
  Sanders醫師表示,我們對這項先期試驗有著如此良好的結果感到非常高興。
  
  到目前為止,已經有199位患者參加了本項試驗,其中有188隻眼睛獲得矯正,這些患者的平均球體等量值(spherical equivalent)為-9.26D,範圍從-3.0D到-20.0D;平均年齡為35歲,其中有56%是女性,患者以前都沒有接受過屈光手術。
  
  有兩片植入鏡片必須去除,其中有一位是圓滑度不良及圓度過大而產生兩邊瞳孔大小不等,另外一位則是圓度過大。
  
  手術後併發症現象者有一例,其中有一位是在第六個月的時候出現視網膜剝離現象;這一例在20/20的結果裡已作了調整。
  
  加拿大的Howard Gimbel醫師表示,在加拿大這項器材已經被核准使用,這項研究結果和他在診所裡所得的經驗是相似的。
  
  Gimbel醫師提出一項資料顯示,38位患者中有58隻眼睛在接受治療後矯正率達到77%,平均球體等量值則從開始的1.98D,降到六個月後的0.45D;他的治療過程中也有發現一例因為圓度過大而必須去除。
  
  Gembel醫師表示,這項先期性研究的結果看起來很好,所獲得視力的結果很好,屈光的結果也很好,早期併發症的機率很低;鏡體的尺寸及不斷改變的圓度則是這項治療的挑戰,長期的穩定性及後期的併發症,仍需要更久的試驗予以觀察。

Toric Phakic Intraocular Lens<

By Jane Salodof MacNeil
Medscape Medical News

Oct. 25, 2004 (New Orleans) — Preliminary results from the first 101 patients in an ongoing U.S. Food and Drug Administration trial of the Toric Phakic Intraocular Lens show encouraging outcomes for the posterior-chamber implantable lens from Staar Surgical Company of Monrovia, California.

Staar consultant Donald R. Sanders, MD, PhD, reported that 82.4% of myopic patients achieved uncorrected visual acuity of 20/20 or better at six months. Ninety-five percent had 20/25 or better, he said during a presentation here at the 2004 joint meeting of the American Academy of Ophthalmology and the European Society of Ophthalmology.

The difference between preoperative best-corrected visual acuity (BCVA) and postoperative uncorrected visual acuity (UCVA) was only 1%, according to Dr. Sanders. The average refractive cylinder correction was 77%, going from a mean of 1.98D preoperatively to 0.45D at six months. While one in five patients gained two or more lines of BCVA, none lost two or more lines.

"We are quite pleased and believe the preliminary results are extremely promising," Dr. Sanders said.

So far, 119 patients have been enrolled in the trial, and 188 eyes have been corrected. Their average spherical equivalent was –9.26D. Average age was 35 years, and 56% of the population were women. None had previous refractive surgery. Their myopia ranged from a spherical equivalent of –3.0D to –20.0D.

Two intraocular lenses had to be removed, one due to poor vault and one because of anisocoria due to large vault, according to Dr. Sanders. Another had to be replaced because of large vault.

The only significant postoperative complication was a retinal detachment at six months. It was repaired with a 20/20 outcome, Dr. Sanders said.

Howard V. Gimbel, MD, MPH, FRCSC, medical director and senior surgeon of the Gimbel Eye Centre in Calgary, Canada, where the device is approved for use, described the trial results as remarkably similar to the experience at his center.

He showed data for 58 eyes in 32 patients. The average correction was also 77%, with the average refractive cylinder measurement going from 1.98D preoperatively to 0.45D at six months. His group had also removed one lens because of excessive vault.

The preliminary results are extremely promising, Dr. Gimbel said, listing "good visual outcomes, good refractive outcomes, [and] low incidence of early complications." He said sizing and consistent vaulting remain a challenge and that long-term results are needed to determine stability and incidence of late complications.

AAO-ESO 2004 Joint Meeting: Abstract PA006. Presented Oct. 24, 2004.

Reviewed by Gary D. Vogin, MD

    
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